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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in SDTM programming and statistical programming within the pharmaceutical and biotechnology sectors, ensuring high-quality deliverables and compliance with clinical data standards and regulatory requirements.
Highest-signal resume keywords
SDTM ProgrammingClinical SAS ProgrammingData Standards ExperiencePharmaceutical Industry ExperienceCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SDTMStatistical ProgrammingData Flow ManagementClinical Data StandardsRegulatory Submission Requirements
Tools & Technologies
ACRFDefine.xmlStudy Data Reviewers Guides
Industry Keywords
PharmaceuticalBiotechnologyCROAnalyticsBiometrics
About the role
Key responsibilities & impact- Lead study-level SDTM programming activities and deliverables
- Deliver annotated Case Report Forms (aCRF), specifications, datasets, define.xml, and Study Data Reviewers Guides
- Collaborate cross-functionally within Analytics and Data Science
- Work with study leads within the Biometrics organization to ensure timely and quality SDTM deliverables
- Represent SDTM Development and Operations in Biogen Portfolio Disease Unit discussions
- Ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of study SDTM activities
- Explore and apply analytics initiatives to optimize clinical data transformation
Requirements
What you’ll need- 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 and regulatory submission requirements, including current global landscape
- Clinical SAS programming experience
- SDTM and statistical programming experience
- Experience working cross functionally with Biometrics stakeholders
Benefits
Comp & perks- 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
- Short term and long-term incentives, including cash bonus and equity incentive opportunities
