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
