Associate Director Biostatistics

The Associate Director, Biostatistics will work in collaboration with the Head of Biometrics and senior leadership to provide strong statistical support to advance Pep Gen’s clinical program. The Associate Director will serve as a statistical subject-matter expert on our cross-functional team, contributing to protocol development, study design, statistical analysis, regulatory submissions, publications and presentations, as well as supporting the management of CRO and external vendors.

• Support the development of statistical sections of clinical study protocols, statistical analysis plans (SAP), and contribute to the analysis and reporting of clinical trial data, including review of Tables, Listings, Figures (TLFs), SDTM and ADaM specifications, clinical study reports (CSR), and regulatory submission documents
• Provide input to help optimize trial designs for pivotal registrational studies; maintain strong competencies in statistical methodology and trial designs, particularly in therapeutic areas such as neuromuscular diseases or other rare diseases, with familiarity with ICH, FDA, and EMA guidelines
• Collaborate with internal and external cross-functional teams to ensure timely statistics deliverables; support oversight of CRO statistical activities and assist in managing contractors and vendors
• Contribute to the development of Biostatistics SOPs and standards
• Effectively communicate statistical concepts in written and verbal context to a broad audience

• Minimum of MS required (Ph.D. preferred) in Biostatistics, Statistics, or other related fields with 8+ years of overall experience in drug development in the pharmaceutical industry
• Experience in therapeutic areas such as neuromuscular diseases or other rare diseases preferred
• Knowledgeable about a range of statistical topics across different phases of drug development, including efficacy, safety, and PRO endpoints
• Regulatory (s)
  NDA/BLA/MAA submission experience preferred
• Must have hands-on experience with SAS and R programming in clinical trials
• Experience supporting or managing CROs and contractors

The estimate full-time salary range for this role is between $205,000 to $236,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.

Pep Gen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account