We are partnering with a Metabolic Start-up Biotech looking to bring on a skilled Head of Biostatistics.
The Head of Biostatistics will lead the statistical strategy and operations for all clinical programs. This individual will provide strategic input into the design, execution, and interpretation of clinical trials, ensuring that high-quality statistical methods are applied to advance the company's therapeutic pipeline. The ideal candidate will have deep expertise in biostatistics and regulatory submissions, particularly in a biotech or pharmaceutical environment, and be comfortable leading both strategic and hands-on tasks in a small, high-growth company.
Key Responsibilities:
- Lead all statistical aspects of clinical development programs from early-phase trials to regulatory submissions, ensuring that statistical methodologies align with regulatory standards and scientific best practices.
- Collaborate closely with cross-functional teams including clinical development, regulatory, medical affairs, and data management to provide statistical input on study design, protocol development, and analysis plans.
- Develop and oversee the execution of statistical analysis plans (SAPs) for clinical trials, including interim analyses, safety monitoring, and final analyses.
- Ensure the integrity, accuracy, and consistency of statistical data and results across clinical trials.
- Provide leadership in the interpretation of study results and preparation of clinical study reports, publications, and regulatory submissions (NDA/BLA/MAA).
- Act as the primary statistical representative in meetings with regulatory agencies (FDA, EMA, etc.) and contribute to key regulatory documents such as briefing books, responses to regulatory questions, and advisory committee presentations.
- Oversee the implementation and adherence to CDISC standards and other regulatory requirements.
- Manage and develop a small team of biostatisticians, ensuring high-quality work and fostering professional growth.
- Collaborate with statistical programmers to ensure seamless integration of biostatistical and programming activities.
- Select, manage, and collaborate with external vendors, consultants, and CROs for statistical services.
- Stay current with advances in statistical methodologies and regulatory requirements to ensure the company’s biostatistics function remains cutting-edge.
Qualifications:
- PhD in Biostatistics, Statistics, or a related quantitative field.
- 10+ years of experience in biostatistics in the biotech or pharmaceutical industry, with at least 3 years in a leadership or managerial role.
- Proven experience in clinical trial design, statistical analysis, and regulatory submissions, including successful interaction with FDA and/or EMA.
- Expertise in advanced statistical methodologies and proficiency with statistical software (SAS, R, etc.).
- In-depth knowledge of CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
- Experience in metabolic disorders or related therapeutic areas is highly desirable.
- Strong leadership, communication, and collaboration skills, with the ability to influence cross-functional teams and work in a fast-paced environment.
- Ability to manage multiple priorities, timelines, and ensure high-quality deliverables.
