Director, Biostatistics

Director, Biostatistics – Pep Gen
• Boston, MA, United States

The Director, Biostatistics will work in collaboration with the Head of Biometrics to provide strong statistical support to advance Pep Gen's DM1 clinical program. As the statistical subject‑matter expert on the cross‑functional team, you will contribute significantly to protocol development, study design, statistical analysis, regulatory submissions, publications and presentations, as well as managing CROs and external vendors.

• Lead the development of statistical sections of clinical study protocols and statistical analysis plans (SAP); conduct 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 strategic input to optimize trial designs for pivotal registrational studies; maintain advanced competencies in statistical methodology and innovative trial designs, particularly in therapeutic areas such as neuromuscular diseases or other rare diseases, and familiarity with ICH, FDA, and EMA guidelines.
• Represent the biostatistics function and proactively collaborate with internal and external cross‑functional teams to ensure timely statistics deliverables; oversee CRO statistical activities and effectively manage contractors and vendors.
• Contribute to the development of biostatistics SOPs and standards.
• Effectively communicate complex statistical concepts in written and verbal contexts to a broad audience.

• Minimum of an MS (Ph.D. strongly preferred) in Biostatistics, Statistics, or 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 broad range of statistical topics across different phases of drug development, including efficacy, safety, and PRO endpoints, and innovative study designs.
• Regulatory (s)
  NDA/BLA/MAA submission experience strongly preferred.
• Hands‑on experience with SAS and R programming in clinical trials.
• Experience managing CROs and contractors.

This role could be in‑person or remote (if remote, occasional travel to the HQ office in Boston, MA, is required).

The estimated full‑time salary range for this role is $228,000 to $250,000. The final compensation package will reflect prior experience, relevant skills, education, qualifications, certifications, business needs, internal equity, and market data. Employees receive a comprehensive total compensation package including discretionary annual bonuses, equity, health insurance (medical, dental, vision), life and disability insurance, paid time off with holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.

Pep Gen is a clinical‑stage biotechnology company advancing the next generation of oligonucleotide therapies to transform the treatment of severe neuromuscular and neurological diseases. Pep Gen’s Enhanced Delivery Oligonucleotide (EDO) platform, built on over a decade of research and development, employs cell‑penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics, generating a pipeline of therapeutic candidates that target the root cause of serious diseases.

Pep Gen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or liability for military status.

Pep Gen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to unsolicited resumes.

Pep Gen is an E‑Verify Employer. For more information about E‑Verify, please see here.