Associate Director, Statistical Programming

Associate Director, Statistical Programming

The Associate Director, Statistical Programming will work in collaboration with the Head of Biometrics and leadership to provide strong programming support to advance Pep Gen’s clinical program. The Associate Director will serve as a technical subject‑matter expert on our cross‑functional team and act as the primary point of accountability for CRO and external vendor programming deliverables, managing these relationships and overseeing the quality of their output.

• Manage and oversee CRO and external programming vendors, serving as the primary point of contact for statistical programming activities; set expectations, monitor performance, and ensure deliverables meet quality, timeline, and budget requirements
• Own the quality oversight of vendor and CRO programming deliverables, including review and validation of SDTM and ADaM datasets, Tables, Listings, and Figures (TLFs), define.xml, and reviewer's guides to ensure accuracy, consistency, and compliance with CDISC and regulatory standards
• Lead and perform the development and validation of analysis datasets and reporting outputs in support of clinical study reports (CSR), regulatory submissions, and other deliverables
• Develop and review dataset specifications (SDTM and ADaM), programming plans, and mock TLF shells to ensure downstream data can be analyzed efficiently
• Provide programming input into statistical analysis plans (SAP) and case report form (CRF) design
• Establish and monitor quality control processes and metrics for outsourced programming work; identify and resolve issues proactively
• Contribute to the development of programming standards, macros, SOPs, and process improvements within the Biometrics function
• Ensure all programming deliverables meet timelines, quality standards, and regulatory expectations (ICH, FDA, EMA)
• Effectively communicate technical concepts in written and verbal context to statisticians, cross‑functional partners, and external vendors

• Minimum of BS/MS in Statistics, Computer Science, Mathematics, Life Sciences, or a related field with 8+ years of statistical programming experience in the pharmaceutical or biotechnology industry
• Expert‑level hands‑on experience with SAS programming in clinical trials; experience with R preferred
• Strong working knowledge of CDISC standards (SDTM, ADaM, define.xml) and regulatory submission requirements
• Demonstrated experience managing CROs and external programming vendors, including oversight of quality and deliverables
• Experience in therapeutic areas such as neuromuscular diseases or other rare diseases preferred
• Regulatory (s)
  NDA/BLA/MAA submission experience preferred
• Strong attention to detail, organizational skills, and ability to manage multiple priorities across studies

The estimate full-time salary range for this role is between $175,000 to $220,000. 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.

Pep Gen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe…