Senior Statistical Programming Lead — Hybrid/Remote

Servier; United States; Hybrid; USD 151,000 - 172,000; Full time

Benefits offered by this job

Medical, dental, vision

Flex time off

401(k)

Life and disability insurance

Recognition programs

Job summary

Servier in the U.S. is a Boston-based biopharmaceutical company focused on advancing science and patient outcomes.

The Sr Manager, Statistical Programming leads study-level programming, performs hands-on work or oversees outsourced deliverables, and ensures compliance with regulatory procedures. Responsibilities include supporting SDTMs/ADaM, managing programming activities for CSR/iDMC, and ensuring quality and traceability of deliverables.

Qualifications

• Masters in Statistics, Engineering, or relevant field required with at least 5 years of experience in statistical programming or biostatistics.
• Good knowledge of CDISC ADaM and SDTM.
• Strong knowledge of regulatory and data submission guidelines.
• Self-directed, technically strong, expert regarding statistical programming processes, management of statisticians at study level.
• Ability to educate internal and external interfaces (CROs and contractors) on the statistical programming processes, and the regulatory requirements.
• Experience with statistical programming in Neurology desirable.

Responsibilities

• Provide programming support for the development or QC of SDTMs, ADaM specifications, ADaM datasets, and TLFs.
• Manage statistical programming activities for a clinical study related to CSR, iDMC, Adhoc analysis and publications.
• Ensure high quality, traceability, reproducibility, and timeliness of statistical programming deliverables to meet regulatory requirements.
• Independently implement routine and non-standard analysis algorithms for assigned projects or studies.
• Collaborate with statisticians, CRO programmers to define and implement analysis requirements and perform sponsor oversight.
• Deliver exemplary performance and solve complex technical problems to inspire other programmers.
• Ensure efficient collaboration with all members of the clinical study team.
• Ensure datasets are CDISC compliant and that regulatory requirements are met.

Skills

SAS

CDISC ADaM/SDTM

Regulatory guidelines knowledge

Leadership / managing programmers

Neurology programming experience

Education

Master's degree in Statistics, Engineering, or relevant field

Job description

Servier in the U.S. is a Boston-based biopharmaceutical company focused on advancing science and patient outcomes.

The Sr Manager, Statistical Programming leads study-level programming, performs hands-on work or oversees outsourced deliverables, and ensures compliance with regulatory procedures. Responsibilities include supporting SDTMs/ADaM, managing programming activities for CSR/iDMC, and ensuring quality and traceability of deliverables.