Principal Biostatistician
Full-Time
United Kingdom (Remote), United Kingdom
Health & Biotech
Health & Biotech
Description
- Serve as the responsible biostatistician on clinical trials.
- Contribute to clinical study protocols.
- Develops Statistical Analysis Plans and/or performs senior quality review of statistical analysis plans
- Review and interpret results from simple to complex clinical studies.
- Provide relevant input in the development and review of CRFs.
- Performs lead review and sets up QC of TFL’s
- Perform critical review of derived datasets specifications and derived datasets (ADaM).
- Presentation of key results
- Contribute to clinical study reports.
- Review simple to complex randomization specifications and dummy randomization schemes.
- Oversee trials outsourced to Contract Research Organizations from a Biostatistics perspective
- Contributes to press releases and scientific papers.
Qualifications
- PhD in statistics or biostatistics or related subjects and 5+ years of experience as a biostatistician in CRO or Pharmaceutical companies OR Masters degree in statistics or biostatistics or related subjects and 10+ years of experience as a biostatistician in CRO or Pharmaceutical companies
- Thorough knowledge of and experience with CDISC standards
- Thorough knowledge of and experience in Regulatory
- Previous experience in working on Phase 2 and 3 studies
- Previous experience in R programming, ESTIMANDS and adaptive designs
- Previous experience in writing of SAP
- Previous experience in creation of analysis for publications
- Strong Leadership and Communication skills
- Knowledge of ADAM and TFL programming
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