Strategic Statistical Programming Lead

Servier; Boston (MA); Hybrid; USD 151,000 - 172,000; Full time

Job summary

Servier in the U.S. is seeking a Senior Manager, Statistical Programming based in Boston.

Responsible for development of statistical programming at study level, hands-on programming or oversight of outsourced work, aligning processes with regulatory requirements and communicating with study statisticians. Requires a Master’s in Statistics or related field, 5+ years in statistical programming, proficiency in SAS, and strong CDISC ADaM/SDTM knowledge.

Qualifications

• Master’s in Statistics, Engineering, or relevant field.
• Proven knowledge of CDISC ADaM/SDTM and regulatory guidelines.
• Experience leading programming teams and communicating with study statisticians.

Responsibilities

• Provide programming support for SDTMs, ADaM specifications, ADaM datasets, and TLFs.
• Manage programming activities for CSR, iDMC, analyses and publications.
• Ensure quality, traceability, reproducibility, and regulatory compliance of programming deliverables.
• Independently implement routine and non-standard analysis algorithms for assigned projects or studies.
• Collaborate with statisticians and CROs to define and implement analysis requirements and provide sponsor oversight.
• Deliver high-quality programming and mentor other programmers.
• Ensure collaboration within the clinical study team and adherence to SOPs.
• Maintain awareness of regulatory requirements (e.g., 21 CFR Part 11) and document control.

Skills

CDISC SDTM/ADaM

Regulatory knowledge

People management

Education

Master's in Statistics, Engineering, or relevant field

Tools

SAS

Job description

Servier in the U.S. is seeking a Senior Manager, Statistical Programming based in Boston.

Responsible for development of statistical programming at study level, hands-on programming or oversight of outsourced work, aligning processes with regulatory requirements and communicating with study statisticians. Requires a Master’s in Statistics or related field, 5+ years in statistical programming, proficiency in SAS, and strong CDISC ADaM/SDTM knowledge.