Sr. Principal Analyst, Statistical Programming
Biogen
18 days ago
Remote friendly (Triangle, NC)
United States
Clinical Research and Development
What You’ll Do
- Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables (internal and/or vendor).
- Author CDISC ADaM analysis data set specifications; identify data issues and document programming endpoint algorithms (study/drug program/TA).
- Manage end-to-end programming from CRF collection through electronic submission, including ESUB components (reviewer’s guide input, annotated CRF, define.xml, and XPTs) and ensure eSUB compliance with SMEs.
- Identify and remediate process inefficiencies; train the department on new processes.
- Serve as Statistical Programming Lead to achieve drug program milestones; assess objectives, escalate issues, and support resource needs.
- Verify consistency and usage of data, analysis, and submission standards across the department.
- Inform internal/external project teams of programming requirements, deliverable status, and resource needs.
Required Skills
- Bachelor’s degree required; MS/PhD in Statistics or Mathematics preferred.
- 10+ years relevant data management/analysis experience.
- 10+ years SAS Base; 7+ years SAS STAT/GRAPH/MACRO.
- 10+ years relevant industry and 10+ years clinical trial experience.
- 5+ years clinical database experience.
- CDISC and/or submissions experience; deep knowledge of drug development and submission requirements (ICH and FDA/EMEA/ROW).
- Familiarity with UNIX; R and other software development packages.
- Familiarity with AI/ML concepts.
Benefits (as listed)
- Medical, Dental, Vision, and Life insurances; Fitness/W wellness reimbursement.
- Short- and Long-Term Disability; 15+ days paid vacation plus end-of-year shutdown.
- Up to 12 paid holidays + personal days; sick time; paid Maternity/Parental Leave.
- 401(k) match; Employee stock purchase plan; Tuition reimbursement up to $10,000/year.
- Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables (internal and/or vendor).
- Author CDISC ADaM analysis data set specifications; identify data issues and document programming endpoint algorithms (study/drug program/TA).
- Manage end-to-end programming from CRF collection through electronic submission, including ESUB components (reviewer’s guide input, annotated CRF, define.xml, and XPTs) and ensure eSUB compliance with SMEs.
- Identify and remediate process inefficiencies; train the department on new processes.
- Serve as Statistical Programming Lead to achieve drug program milestones; assess objectives, escalate issues, and support resource needs.
- Verify consistency and usage of data, analysis, and submission standards across the department.
- Inform internal/external project teams of programming requirements, deliverable status, and resource needs.
Required Skills
- Bachelor’s degree required; MS/PhD in Statistics or Mathematics preferred.
- 10+ years relevant data management/analysis experience.
- 10+ years SAS Base; 7+ years SAS STAT/GRAPH/MACRO.
- 10+ years relevant industry and 10+ years clinical trial experience.
- 5+ years clinical database experience.
- CDISC and/or submissions experience; deep knowledge of drug development and submission requirements (ICH and FDA/EMEA/ROW).
- Familiarity with UNIX; R and other software development packages.
- Familiarity with AI/ML concepts.
Benefits (as listed)
- Medical, Dental, Vision, and Life insurances; Fitness/W wellness reimbursement.
- Short- and Long-Term Disability; 15+ days paid vacation plus end-of-year shutdown.
- Up to 12 paid holidays + personal days; sick time; paid Maternity/Parental Leave.
- 401(k) match; Employee stock purchase plan; Tuition reimbursement up to $10,000/year.