Director of Biostatistics - Permanent - San Francisco, CA

Proclinical Staffing are partnered with a truly exciting Mid-Sized Biotech in their search for a Director of Biostatistics.

Primary Responsibilities:

The business specializes in Oncology and Rare Disease studies where they are now at the most critical point of their18 year history. With several studies in their Late Phase portfolio and a highly innovative Early Phase portfolio, the business is keen to capitalize on this by growing several critical functions with Biometrics at a focus point of this expansion.
The successful candidate will lead the statistical strategy and execution across multiple development programs. This role will collaborate with cross-functional teams, including Clinical Development, Regulatory, Manufacturing, and Commercial, to design and execute clinical trials. The successful candidate will also manage external statisticians and statistical programmers, ensuring that all statistical components of clinical studies meet the highest standards of quality and compliance.

Skills & Requirements:

• D. in Statistics, Biostatistics, Mathematics, or a related field.
• 7+ years of experience in clinical trial development.
• Proven track record in managing the delivery of statistical projects by CROs.

The Director of Biostatistics' responsibilities will be:

• Collaborate with Clinical Development, Regulatory, Manufacturing, and Commercial teams on the design and execution of clinical trials within the company's portfolio.
• Lead the strategic development of the Biostatistics function in partnership with other members of senior leadership group
• Oversee the statistical components of clinical studies managed by CROs and independent contractors, ensuring timely and quality delivery of analysis results.
• Work closely with Statistical Programming to generate and validate statistical analyses for both internal and external presentations.
• Ensure CDISC electronic data packages meet completeness, regulatory standards, and submission readiness in collaboration with Statistical Programming.
• Stay informed on the latest regulatory requirements and scientific advancements in statistical methods for clinical trials.
• Consult with internal audit teams to assess the regulatory compliance of CROs concerning statistical SOPs.
• Contribute to the governance and development of biostatistical SOPs, ensuring best practices across the organization.

Compensation:

• $230,000 to $270,000 per annum, dependent on experience.

Location:

• This position is hybrid working within San Francisco Bay Area.
• This position can be amended to Remote working for the right candidate.

If you are having difficulty in applying or if you have any questions, please contact George Breen at

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.