Senior Statistical Programming Lead - Trials & Submissions

Ipsen Group; Cambridge (MA); Hybrid; USD 140,000 - 210,000; Full time

Job summary

Ipsen Innovation is seeking a Sr. Manager, Statistical Programming to lead programming on multiple compounds/studies within Oncology, Rare Disease, or Neuroscience. The role combines hands-on SAS work with leadership to ensure quality and timely results for global regulatory submissions.

The ideal candidate has 8+ years in pharmaceutical/biotech CRO environments, familiarity with CDISC standards, SDTM/ADaM, and strong reporting skills. English required; French language knowledge is a plus.

Qualifications

• Proficiency in SAS programming is essential.
• Familiarity with CDISC standards, SDTM and ADaM is required.
• Experience in reporting and table, listing, figure programming (TFLs) is expected.
• Bachelor or MSc in statistics, mathematics or a scientific discipline is required.

Responsibilities

• Lead programming on multiple studies and ensure timely, high-quality deliverables.
• Oversee outsourced programming work for budget, quality and timelines.
• Contribute to development and implementation of SAS standards and validation.
• Prepare study documentation ready for audit and regulatory submissions.

Skills

SAS proficiency

CDISC familiarity

SDTM/ADaM programming

TFL reporting programming

Education

Bachelor or MSc in Statistics or Mathematics

Tools

R experience

Job description

Ipsen Innovation is seeking a Sr. Manager, Statistical Programming to lead programming on multiple compounds/studies within Oncology, Rare Disease, or Neuroscience. The role combines hands-on SAS work with leadership to ensure quality and timely results for global regulatory submissions.

The ideal candidate has 8+ years in pharmaceutical/biotech CRO environments, familiarity with CDISC standards, SDTM/ADaM, and strong reporting skills. English required; French language knowledge is a plus.