Biostatisticien principal FSP, Puissance statistique et conception des études
Core
Principal Biostatistician providing statistical support for pharmaceutical clinical trials, focusing on study powering, design, and regulatory submissions.
Role type
Senior IC biostatistician (clinical trials)
Builds
Clinical study reports, regulatory submissions (IND/NDA), and statistical analysis plans
Domain
Pharmaceutical/Biotech clinical trials
Required skills
Sample size and power calculations, Statistical analysis plan (SAP) authoring, SAS/R programming, CDISC standards (SDTM/ADAM/CDASH), Regulatory guidelines (FDA/ICH), Clinical study report (CSR) authoring, Data validation programming
Preferred skills
Immunology therapeutic area, Bayesian methods
Technologies
SAS, R, CDISC (SDTM, ADAM, CDASH)
Responsibilities
Perform sample size and power calculations for study design, Author statistical analysis plans, Collaborate with Data Management and Clinical Development teams, Validate efficacy analysis datasets and TLFs, Interpret study results and review accuracy, Participate in IND or NDA activities
Seniority
Senior, hands-on IC