A Start-up Biotech company is looking for an Associate Director who can lead both the Biostatistic and Statistical Programming teams. This opportunity is a fully remote position and will spearhead both groups into late-phase oncology clinical trials.
Details:
- Enable achievement of major Biostatistics and Programming deliverables and milestones for oncology programs in coordination with other functions including Clinical Data Management, Medical, Clinical Science, Medical Writing, Clinical Operations, and Pharmacovigilance
- Work in collaboration with internal and external partners in the study design, support endpoint selection and sample size calculations, analysis, interpretation, and publication of clinical trial data
- Execute protocols, statistical analysis plans, clinical database design, study reports, ensure statistical integrity of presentations and publications of clinical studies
- Provide support of Biostatistics and Programming deliverables (i.e. SAP, TFL, SDTM, ADaM creation, etc.)
- Responsible for the quality of the data of each Elevar clinical trial, as well as quality of other Biostatistics and Programming deliverables
- Identify and manage external vendors and serve as a key Biostatistics and Programming strategic direction and liaison with external organizations for Elevar clinical trials
Requirements:
- PhD in related discipline preferred
- 15+ years of experience in pharmaceutical, biotech or equivalent; global experience strongly preferred
- Broad knowledge of statistical methodologies
- Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
- Review CRF, database design, and edit check specs
- Review study quality surveillance plan and monitor study conduct
- Prepare and/or review SAP, TFL shells and specifications for variable derivation
- Significant NDA submissions
*This position is fully remote with no requirement to relocate.
