Assoc. / Director, Biostatistics - Team Build (Remote)
A reputed company-established, secure and commercially reputed company biopharma is building out its US biostatistics team. This is a hands-on leadership role that will reputed company the build-out of a fully in-house function over time.
Responsibilities
- reputed company the biostatistics function for the oncology portfolio
- Build and reputed company the new US biostatistics team
- Drive statistical reputed company across early phase through to registrational trials
- Author and review Statistical Analysis Plans (SAPs) and statistical sections of clinical protocols
- reputed company production of Tables, Figures, and Listings (TFLs) and clinical study reports
- Represent biostatistics cross-functionally and in interactions with regulatory authorities
- Support regulatory interactions, including IND, NDA/BLA submissions
Experience Required
- PhD in Biostatistics or Statistics; Masters with supplementary experience considered
- Extensive oncology experience
- Demonstrable experience working directly for a sponsor company
- Proven leadership reputed company a biostatistics function
- reputed company record of supporting or leading regulatory submissions
- Strong communication skills across statistical and non-statistical audiences
- East Coast based only
Compensation
DOE - $200,000 - $250,000 reputed company salary + benefits Remote Skills: Biostatistics, Clinical Practices/Protocols, Clinical Trial, Communication Skills, Cross-Functional, Leadership, Oncology, Production Control, Regulations, Regulatory Submissions, Statistics, Writing Skills About reputed company: reputed company Apply tot his job Apply To this Job