Sr. SDTM Programmer
Biogen
Summary
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 United States and Europe.
Job description
About This Role
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 United States and Europe.
What You'll Do
You will lead study level SDTM programming activities and deliverables (annotated Case Report Form (aCRF), specifications, datasets, define.xml, Study Data Reviewers Guide, etc.). 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.
Who You Are
You are a Clinical SAS Programmer with some Lead experience or looking to lead a study. You are someone who is passionate about data, data structures, data transformations and taking/learning about initiatives using Analytics to optimize the transformation of clinical data. You are experienced in SAS and keen to explore technologies beyond SAS in the clinical trial space.
Required Skills
- 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.
Requirements
- Bachelor's degree required
- 2+ years relevant work experience with a focus on SDTM and statistical programming
- 2+ years proven data standards experience with a focus on SDTM and end to end data flow
- 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 Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- 15 Days Paid Vacation
- End-of-Year Shutdown
- 12 Paid Holidays
- 80 Hours Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.