Senior Statistical Programming Lead, CRO Oversight

OSI; Northern (KY); Hybrid; USD 175,000 - 220,000; Full time

Job summary

PepGen is seeking an Associate Director of Statistical Programming to lead and oversee CRO/external programming vendor activities, ensuring SDTM/ADaM quality and regulatory compliance. The role serves as a technical SME on cross-functional teams and drives efficient data provisioning for CSR, regulatory submissions, and other deliverables.

The ideal candidate brings 8+ years in statistical programming within pharma/biotech, expert SAS, CDISC proficiency, and vendor management experience, with

Qualifications

• BS/MS in Statistics, CS, Mathematics or Life Sciences with 8+ years of statistical programming in pharma/biotech.
• Expert-level SAS programming in clinical trials; R experience preferred.
• Strong CDISC SDTM/ADaM knowledge and regulatory submission experience.
• Experience managing CROs and external vendors and ensuring quality/deliverables.
• Therapeutic area experience in neuromuscular or related diseases preferred.

Responsibilities

• Oversee CRO/external programming vendors as primary contact; set expectations and timelines.
• Ensure SDTM/ADaM datasets, TLFs, define.xml, and reviewer guides meet standards.
• Lead development/validation of analysis datasets and CSR outputs.
• Create dataset specifications and programming plans to enable downstream analysis.
• Contribute to SAP and CRF design; establish QC processes and metrics.
• Promote standards, macros, SOPs, and process improvements in Biometrics.
• Ensure timely, quality programming deliverables meeting regulatory expectations.
• Communicate complex concepts to statisticians and partners.

Skills

SAS programming

R programming

CDISC standards

Vendor management

Cross-functional collaboration

Statistical programming

Education

BS/MS in Statistics, Computer Science, Mathematics, Life Sciences, or related field

Tools

SAS

define.xml

Job description

PepGen is seeking an Associate Director of Statistical Programming to lead and oversee CRO/external programming vendor activities, ensuring SDTM/ADaM quality and regulatory compliance. The role serves as a technical SME on cross-functional teams and drives efficient data provisioning for CSR, regulatory submissions, and other deliverables.

The ideal candidate brings 8+ years in statistical programming within pharma/biotech, expert SAS, CDISC proficiency, and vendor management experience, with