Available Position (Company name withheld)

• 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

About PepGen

PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.

EEO Statement
PepGen 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; affectional or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.

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