[Hiring] Senior Study Data Tabulation Model Programmer @Biogen

Role Description

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.

You will lead study level SDTM programming activities and deliverables:

• Annotated Case Report Form (aCRF)
• Specifications
• Datasets
• Define.xml
• Study Data Reviewers Guide

Collaborating cross-functionally within Analytics and Data Science, you will work with other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study. You will represent SDTM Development and Operations (Dev & Ops) in the Biogen Portfolio Disease Unit (DU) discussions. You will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

Qualifications

• Clinical SAS Programmer with some Lead experience or looking to lead a study.
• Passionate about data, data structures, data transformations, and learning about initiatives using Analytics to optimize the transformation of clinical data.
• Experienced in SAS and keen to explore technologies beyond SAS in the clinical trial space.

Requirements

• 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/biotechnology/CRO industry experience required.
• Good knowledge of clinical data standards, regulatory submission requirements including current global landscape.
• Working cross-functionally with Biometrics stakeholders.

Benefits

• 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
• Employee Resource Groups participation