Title: Associate Director, Biostatistics
Salary: $177,000/yr-$220,000/yr, + 15% Target Bonus, + 90k RSUs
Hybrid in the Bay Area.
We have partnered with a dynamic clinical stage biotech company aimed at treating fibrosis across multiple diseases areas. Founded in the mid-90s, this company has already managed to get multiple drugs approved. Their current pipeline is comprised of 4 compounds in Phase 3 and 4 compounds in 1 and 2. While this company has followed the trend of focusing in small molecules in the oncology therapeutic area, they also carry a multi-targeted approach, setting them apart from other cancer therapies that may target a single pathway. By blocking multiple pathways their compounds provide more comprehensive inhibition of cancer progression. Furthermore, they have a total revenue of over $1.6 billion (2022) and are projected to make more come 2024.
The Associate Director will be responsible for:
- Clinical study concepts, case report forms, clinical study reports, regulatory documents, scientific publications, internal and external meetings, and presentations.
- The production of biostatistics output by providing oversight of the work performed by CROs and consultants to ensure timeliness and quality of data.
- Developing Departmental standards i.e (CRF design, ADaM datasets, TFL Mocks).
- Global regulatory interactions including filings, written, oral and onsite.
- Ensuring all biostatistics activities comply with industry norms, health authority regulations, ICH/GCP.
The Associate Director should have the following Key Qualifications:
- PhD in Biostatistics or Statistics.
- At least 8 years of experience in pharma / biotech industry. (Oncology experience).
- Extensive knowledge of clinical trials methodology. Proficiency in SAS required, and knowledge of (R) is a plus.
- FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments and industry standards in statistics and drug development.
- Advanced knowledge of CDISC requirements for SDTM and ADaM.
- Medical Benefits fully covered (Dental, Eyes, Medical)