Thermo Fisher Scientific Careers

Discover Impactful Work:

• Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

A day in the Life:

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational products through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports tothe Clinical Team Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.
• Job Complexity Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
• Job Knowledge Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
• Supervision Received Normally receives detailed instructions on all work.
• Business Relationships Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.

Keys to Success:
Education

• Bachelor's degree in life related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processesGood oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

• As a Senior Programmer Analyst, you will act as the lead programmer, supervising the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting.

Your responsibilities will include (but are not limited to) the following:

• Programming lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.
• Assumes leadership responsibility as a contributing member of a multidisciplinary project team, communicating actively and frequently with other team members and ensuring adherence to SOPs.
• Independently create, maintain, and validate programs for transferring data across multiple systems, combine and store data from various sources, generate reports and summaries, using SAS for creating listings, tables, and figures.
• Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
• Provides training, guidance, and project leadership to junior team members.
• Provides general infrastructure support to the department, including representing the company at industry conferences, presenting at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies such as the development of departmental working practice documents and SOPs.
• Provides input into bidding process as requested.

Education and Experience:

• Master's degree in computer science, statistics, biostatistics, mathematics or related field and at least 8 years' experience in hands-on programming, with lead programming experience.

OR

• Bachelor's degree in a related discipline and at least 10 years' experience in hands-on programming, with lead programmer experience.

Knowledge, Skills and Abilities:

• In-depth understanding of one or more programming languages. SAS required.
• ADaM, SDTM and TLF programming experience
• Proven experience as an independent, lead programmer.
• Experience programming complex analysis datasets and outputs (efficacy, complex lab and regulatory requests)
• Strong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Demonstrated leadership ability and ability to work on a multi-disciplinary project team, training and mentoring others
• Solid project management skills to act as project lead across the most challenging and complex projects.
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.

Responsibilities:

According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.

• Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively communicates any risks to project leads.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• May support scheduling of client and/or internal meetings.
• May review and track of local regulatory documents.
• May provide system support (i.e., Activate & eTMF). May support RBM activities.
• May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s).
• Transmits documents to client and centralized IRB/IEC.
• Maintains vendor trackers.
• Supports start-up team in Regulatory submissions.
• Works directly with sites to obtain documents related to site selection.
• Assists the project team with the preparation of regulatory compliance review packages.
• Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
• May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel.
• Documents in real time all communication, attempts an follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up.
• Ensure compliance with the plan and escalate concerns/non-compliance to management.
• May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites.
• Harness this knowledge base when performing local tiering of sites.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices.
• Trains new personnel in processes and systems.
• Utilizes local knowledge to contribute to the identification and development of new sites.

PLEASE NOTE: Canvassing in any form will lead to automatic disqualification, only shortlisted candidates will be contacted. Please be informed that Kisii County Public Service Board (CPSB) DOES NOT USE AGENTS nor CHARGE ANY FEE for its services.

The copies of National ID Card and Academic Certificates MUST be certified by a commissioner for Oaths.

Clearance documents for purposes of compliance with the provisions of Chapter Six (6) of the Constitution of Kenya, 2010 will be required for those shortlisted and MUST Submit Copies of the following clearances during the interview:

• Tax compliance certificate;
• Higher Education Loans Board (HELB) Compliance certificate;
• Ethics and Anti-Corruption Commission (EACC) self-declaration form;
• Certificate of Good Conduct;
• Credit Reference Bureau (CRB) certificate
• Women and people living with disability are encouraged to apply.
• Only shortlisted candidates will be contacted.

Applications should be submitted in a sealed envelope clearly indicating the position applied for; department, whilst enclosed together with a copy of National ID, detailed Curriculum Vitae (CV) and copies of all relevant certificates and testimonials, so as to reach on or before
12th March, 2024 at 5.00p.m and addressed to:

The Ag. -Secretary
Kisii County Public Service Board
P.O Box 1848-40200, KISII

Delivery application can be dropped at the Kisii County Public Service Board offices situated along the Kisii –Kilgoris road, near the Kisii Cathedral road junction

Discover Impactful Work:

• The ACRA within Site Support Solutions will perform delegated activities at assigned investigator sites under the supervision of the Principal Investigator. Facilitates GCP, protocol adherence, patient safety, quality delivery, and customer satisfaction. Ensures compliance with PPD, sponsor, and site processes, as appropriate. Provides support with regards to site preparedness and logistics on assigned projects. Assists with site management tasks to ensure protocol, regulatory, and SOP compliance and to guarantee subject safety, data integrity, and site compliance. Travel to sites is required.

A Day in the Life:
The Assistant CRA may participate in tasks similar to the following, as delegated and supervised by the Principal Investigator:

• Data entry
• Essential document collection; regulatory and start-up activities
• Query resolution
• Chart abstraction
• Revieing patient charts to support recruitment
• Quality management and inspection readiness; identify and document protocol deviations
• Tracking biopsies
• Maintaining adequate study supplies inventory
• Supporting development of materials and tools
• Setting up electronic devices used in the study

Education

• Master’s Degree in life sciences.
• Previous clinical research experience would be an advantage.

Knowledge, Skills, Abilities

• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
• Effective oral and written communication skills
• Excellent interpersonal and customer service skills
• Good organizational and time leadership skills and strong attention to detail, with a proven track record to handle multiple tasks efficiently and optimally
• Proven flexibility and adaptability
• Strong attention to detail
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable.
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
• Excellent English language and grammar skills

• As a Senior Programmer Analyst, you will act as the lead programmer, supervising the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting.

Your responsibilities will include (but are not limited to) the following:

• Programming lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.
• Assumes leadership responsibility as a contributing member of a multidisciplinary project team, communicating actively and frequently with other team members and ensuring adherence to SOPs.
• Independently create, maintain, and validate programs for transferring data across multiple systems, combine and store data from various sources, generate reports and summaries, using SAS for creating listings, tables, and figures.
• Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
• Provides training, guidance, and project leadership to junior team members.
• Provides general infrastructure support to the department, including representing the company at industry conferences, presenting at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies such as the development of departmental working practice documents and SOPs.
• Provides input into bidding process as requested.

Education and Experience:

• Master's degree in computer science, statistics, biostatistics, mathematics or related field and at least 8 years' experience in hands-on programming, with lead programming experience.

OR

• Bachelor's degree in a related discipline and at least 10 years' experience in hands-on programming, with lead programmer experience.

Knowledge, Skills and Abilities:

• In-depth understanding of one or more programming languages. SAS required.
• ADaM, SDTM and TLF programming experience
• Proven experience as an independent, lead programmer.
• Experience programming complex analysis datasets and outputs (efficacy, complex lab and regulatory requests)
• Strong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Demonstrated leadership ability and ability to work on a multi-disciplinary project team, training and mentoring others
• Solid project management skills to act as project lead across the most challenging and complex projects.
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.

Responsibilities:

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively communicates any risks to project leads.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members. 
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. 
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. 
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• May support scheduling of client and/or internal meetings.
• May review and track of local regulatory documents.
• May provide system support (i.e., Activate & eTMF). May support RBM activities.
• May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s).
• Transmits documents to client and centralized IRB/IEC.
• Maintains vendor trackers. 
• Supports start-up team in Regulatory submissions.
• Works directly with sites to obtain documents related to site selection.
• Assists the project team with the preparation of regulatory compliance review packages.
• Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
• May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel.
• Documents in real time all communication, attempts an follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up.
• Ensure compliance with the plan and escalate concerns/non-compliance to management.
• May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites.
• Harness this knowledge base when performing local tiering of sites.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices.
• Trains new personnel in processes and systems.
• Utilizes local knowledge to contribute to the identification and development of new sites.

• As a Principal Programmer within DTS, you will perform specification, development, quality validation and regulatory submission compliance for PPD developed CDISC SDTM and CDISC eCRT (Define.xml) programming deliverables, using Windows SAS Grid. You will deploy Spotfire dashboards, Safety notifications and reporting for Medical Monitor review and regulatory actions. As a DTS team member, you will be a key team player for internal Biostatistics interactions and client engagement on CDISC submission topics, or internal contact for procedural and technical solutions.
• Our Biostatistics & Programming (B&P) department are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry leading CDISC expertise and programming leadership through global delivery, consistent quality adherence and scientific insight.

Your responsibilities will include (but are not limited to) the following:

• Act as programming lead on Phase II-IV group of studies.
• As programming lead assume leadership responsibility as a contributing member of a global project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.
• Provides input into bidding process as requested.
• May provide general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials etc.
• Provides training, guidance, and project leadership to junior team members. - Develop instructional training and education materials for the wider B&P community.
• Creation of specifications, development, validation, and delivery of CDISC SDTM and regulatory deliverables (eCRT Define.xml, SDTM aCRF)
• Analysing and combining data from a variety of sources and structures including virtual trials, wearables, eCOA, etc.
• Generating visualizations (Spotfire), Statistical safety reports (TLFs), safety event notifications and data alerts for study teams.
• Provide consult, analysis, and support across various therapeutic area studies in their CDISC compliance and consistency in mapping.

To be considered for the role you should have the following qualifications and experience:

• Master's degree in computer science, statistics, biostatistics, mathematics, or related field and at least 4 years of experience that provides the knowledge, skills, and abilities to perform the job requirements,

OR

• Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent formal academic / vocational qualification, and at least 6 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

Knowledge/Skills:

• In-depth understanding of one or more programming languages
• Strong attention to detail
• Strong problem solving and innovative skills
• Strong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Capable of independently and effectively organizing and managing multiple assignments with challenging timelines
• Capable of adapting and adjusting to changing priorities
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Demonstrated leadership, initiative, and motivation
• In-depth understanding of relational data base structure and complex data systems
• Capable of training and mentoring others
• Demonstrated leadership ability and ability to work on a multi-disciplinary project team
• Solid project management skills to act as project lead across the most challenging and complex projects
• Capable of effectively capturing biostatistical metrics
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.

Position Overview:

• Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.

Responabilties for the role:

• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned.
• Completes and documents study-specific training.
• Orients and trains on any CRG/study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient facing materials and review translations, as directed.
• Supports site staff with the vendor related qualification process, where applicable.
• Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
• Provides support to follow-up on site staff training, as applicable.
• Coordinates and supports logistics for IM attendance, as directed.
• Supports maintenance of vendor trackers, as directed.
• Coordinates study/site supply management during pre-activation and subsequent course of the study.
• Supports Essential Document collection, review and updating in systems, as applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
• Supports ongoing remote review of centralized monitoring tools, as directed.
• Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
• Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
• May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
• May perform a specific role profile for FSP opportunities according to Client requests.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Keys to Success:
Education and Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 to 2 years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and CRG procedural documents
• Effective oral and written communication skills
• Excellent interpersonal and customer service skills
• Good organizational and time management skills and strong attention to detail, with tried ability to handle multiple tasks efficiently and effectively
• Proven flexibility and adaptability
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Advanced digital literacy with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
• Excellent English language and grammar skills

• We are looking for Principal Biostatisticians who implement diverse statistical tasks supporting the clinical development programs. The tasks mainly focus on handling the statistical activities performed by the biometrics CRO and on guarantying by means of thorough review outstanding statistical quality. You will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the CSR.

Key Accountabilities/Responsibilities:
The Principal Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:

• Serves as the responsible biostatistician on Phase I to III clinical trials, ranging from relatively simple or complex.
• Contributes to clinical study synopses and protocols.
• Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
• Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
• Provides relevant input in the development and review of CRFs.
• Performs lead review and sets up internal QC of TFLs.
• Performs critical review of derived datasets specifications and derived datasets (ADaM).
• Contributes to clinical study reports.
• Reviews simple to complex randomization specifications and dummy randomization schemes.
• Participates in bid defense meetings.
• Oversight of project financials.
• Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
• Contributes to press releases and scientific papers.

Skills and Experience:

• Master’s degree in statistics or biostatistics required.
• Minimum of 6-8 years of biostatistical experience, plus lead statistician experience.
• Experience in handling CROs and vendors.
• Experience with Data Monitoring Committees (DMC's)
• Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Proficient with other statistical software such as R, EAST, Winbugs is a plus.
• Detailed knowledge of and experience with CDISC standards is desired.
• Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Displays excellent communication skills with proven leadership ability.
• Knowledge of ICH-GCP and other applicable legislation to successfully implement the clinical study.