Director, Biostatistics
Tasks
- Author and review statistical sections of regulatory submissions
- Collaborate across clinical development clinical operations medical affairs and regulatory affairs
- Design adaptive Bayesian and estimand based trials
- Develop statistical analysis plans sample size justifications and randomization strategies
- Ensure compliance with ICH E6 E8 E9 E9R1 E10 E17
- Integrate quantitative evidence from early development into late stage design decisions
- Lead generation and review of TLFs for clinical study reports
- Lead statistical strategy for clinical programs
- Maintain biostatistical standards SOPs templates and best practices
- Mentor biostatisticians and support workforce planning and recruitment
- Oversee IDMC DSMB activities charter and SAP development and unblinded analyses
- Oversee statistical analyses interim primary and final analyses and safety reviews
- Oversee vendor and CRO selection qualification and statistical deliverable review
- Own biostatistical activities from study design through regulatory submission
- Represent biostatistics in FDA and EMA scientific meetings
- Review CDISC SDTM ADaM specifications define xml and reviewer guides
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Adaptive trial design | Analysis Plan | Bayesian Methods | CDISC | CRO oversight | DSMB | Define-XML | ECTD | Estimand framework | ICH E10 | ICH E17 | ICH E6 | ICH E8 | ICH E9 | ICH E9(R1) | IDMC | Interim analysis | Python | R | Randomization Strategy | SAS | SDTM | Sample Size | Sample Size Justification | Statistical Analysis | Statistical Analysis Plan | Trial design
Education
Regions
Countries
States
Cities
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