Title: Associate Director, Biostatistics
Salary: $190,000/yr-$220,000/yr, + 30% Target Bonus, + Substantial Equity
Hybrid in the Bay Area. (Fully remote candidates can be considered if they are based in the PST time zone).
Summary:
We have partnered with a dynamic clinical stage biotech company aimed at treating fibrosis across multiple diseases areas. This company was founded in 2012 and has already managed to get 2 promising indications to phase 3 of development. Their prolific pipeline is comprised of 4 different programs with 4 indications in phase 2 of development and a robust R&D pipeline with 5 indications aimed at entering the clinic by the end of 2024. While this company has yet to get their first product approved their leadership team is made up of some of the top industry players that have already generated successful approvals from larger biotech organizations. Furthermore, they just received a significant financial backing from a global top 10 biopharma company that give them a long-term cash runway for the next 4+ years. If you are looking for a fast paced clinical stage company poised for explosive growth in the coming years don't hesitate to apply to learn more.
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 or MS in statistics or mathematics.
- At least 3 years of experience in pharma / biotech industry. (Rare disease or Oncology experience is a plus).
- 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.
Benefits Perks:
- Medical Benefits fully covered (Dental, Eyes, Medical)
- Unlimited PTO
- Relocation Package (if needed).
