The (Senior) Study Data Tabulation Model (SDTM) Programmer will be part of the SDTM Development and Operations organization that is evolving and responsible for fulfilling all of Biogen’s SDTM needs with presence in the Unites States and Europe.
Lead study level SDTM programming activities and deliverables (annotated Case Report Form (aCRF), specifications, datasets, define.xml, Study Data Reviewers Guide, etc.)
Collaborate cross-functionally within Analytics and Data Science with other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study
Represent SDTM Development and Operations (Dev & Ops) in the Biogen Portfolio Disease Unit (DU) discussions
Ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities
Bachelor’s degree required
2+ years relevant work experience with a focus on SDTM and statistical programming (4+ years’ experience for Senior SDTM Programmer consideration)
2+ years proven data standards experience with a focus on SDTM and end to end data flow (3+ years’ experience for Senior SDTM Programmer consideration)
2+ years of Pharmaceutical/Biotech/CRO industry experience required
Good knowledge of clinical data standards, regulatory submission requirements including current global landscape
Experience working cross functionally with Biometrics stakeholders
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year