Senior Statistical Programming Lead | SDTM/ADaM Expert

Penfield Search Partners Ltd; Fairfield (CT); Remote; USD 150,000 - 210,000; Full time

Job summary

Penfield Search Partners Ltd is seeking a Senior Manager of Statistical Programming to lead programming activities for pharmaceutical development. The role bridges Biostatistics and CDM, ensuring high-quality CRFs, data delivery, and regulatory-ready outputs.

The candidate will guide SDTM/ADaM/TLF programming, review SAPs, manage CROs, and drive SOPs and open-source reporting tools across cross-functional teams, with a focus on quality and regulatory compliance.

Qualifications

• Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or related field.
• Minimum of 6 years of statistical programming experience in pharma/biotech/CRO environments.
• Advanced SAS and R programming skills, with experience using Git for version control.
• Hands-on SDTM, ADaM, and TLF programming experience.
• Python programming is desirable.
• Knowledge of CDISC standards and regulatory submission requirements.

Responsibilities

• Provide programming leadership and oversee study-to-compound level programming deliverables.
• Review SAP, Data Presentation Plan, and Table Shells to align with objectives.
• Lead programming to produce/validate SDTM, ADaM, and TLF for CSR and regulatory needs.
• Manage CROs and contractors to ensure quality, timelines, and budget compliance.
• Collaborate with statisticians and CDM to ensure accurate final databases, analyses, and reports.
• Develop company tools (R packages, macros, dashboards) to enhance efficiency.
• Lead NDA eSubmission package preparation and define.xml creation.

Skills

SAS programming

R programming

SDTM/ADaM knowledge

Programming leadership

Regulatory submission knowledge

CDISC standards familiarity

Education

Master's degree in Statistics/Biostatistics/Math/CS

Tools

Git

Shiny

Pinnacle 21

Job description

Penfield Search Partners Ltd is seeking a Senior Manager of Statistical Programming to lead programming activities for pharmaceutical development. The role bridges Biostatistics and CDM, ensuring high-quality CRFs, data delivery, and regulatory-ready outputs.

The candidate will guide SDTM/ADaM/TLF programming, review SAPs, manage CROs, and drive SOPs and open-source reporting tools across cross-functional teams, with a focus on quality and regulatory compliance.