Job Title:
Clinical Statistician, Data Science Location:
United Kingdom (Remote) Type:
Full-time, Permanent Responsibilities:
• Contributes to parts of the planning, execution and reporting of clinical/observational studies including post hoc, HTA, regional, PK-PD or Biomarkers analyses in collaboration with the Study Statistician.
• Is responsible for the quality and timeliness of assigned statistical tasks following company working practices and regulatory guidelines.
• Reviews synopsis, protocol, statistical analysis plans (SAP), Case Report Form (CRF), Data Validation Plans, tables listings and figure (TLF) specifications.
• Performs statistical analyses in accordance with protocol, SAP, good statistical practice, and available regulatory guidelines.
• Reviews outputs for validity and completeness, QC inferential statistical analyses.
• Reviews Clinical Study Reports (CSR), other reports or publications.
• Accumulates and maintains relevant knowledge of statistical methods for clinical trials and regulatory guidelines in the pharmaceutical industry and the Primary Focus (PF) of interest.
Organizational Context:
Using state-of-the-art methodology and the most innovative approach, SRS generates compelling evidence using clinical trials or real-world data (RWD) to ensure successful and timely regulatory approval, pricing, reimbursement, and patient access.
• This position is an individual contributor role.
• This position is a remote position.
• This position is part of Biostatistics, Medical Affairs (MA) statistics, regional Statistics, Methodology & Simulations or Exploratory statistics.
Qualifications:
• 5 years' experience within Statistics / Data Science at a pharmaceutical company.
• M.S in Biostatistics, Statistics or related scientific field with proven experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry.
• Good skills in SAS and R required.
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