Senior Principal Analyst, Statistical Programming
Biogen
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $134,000 - $179,000 per year
Job Level
About the role
- The Senior Principal Analyst, Statistical Programming is primarily responsible for leading the Management of several study SDTM operating activities and deliverables (aCRF, specifications, datasets, define.xml, SDRG, etc) under an FSP operating model and at the Portfolio Level.
- Collaborating cross-functionally within Biometrics, he/she may serve as a leader or provide support in developing and implementing best practices and processes for optimization of the SDTM delivery model.
- He/She reviews the study pipeline and serves as a first line for routine day-to-day activities for FSP resources, and review of metrics related to SDTM quality and timelines.
- This role will ensure quality SDTM package delivery to the Statistical Programming group through oversight of the model.
- He/she leads or participates in cross-functional teams to coordinate ADaM Data standardization efforts across the Quantitative Sciences and Development Organization (QSDO).
- He/she will be instrumental and directly contribute/develop in building ADaM templates.
- Acting as an ADaM consultant, he/she supports and educates colleagues and clinical study teams across QSDO.
- He/she participates in external industry data standards development teams, as appropriate, and contributes to the development of clinical data standard models on QSDO's behalf.
Requirements
- Bachelor’s Degree is required.
- 8+ years relevant work experience with a focus on data statistical programming is required.
- Strong knowledge of CDISC standards (SDTM/ADaM), regulatory and drug submission requirements, and current regulatory trends including global landscape is required.
- Macro Programming experience is required.
- Deep understanding of drug development and biopharmaceutical industry is required.
- Strong project management skills, and the ability to effectively lead and collaborate with various business functions are required.
- High attention to detail, including proven ability to manage multiple, competing priorities, is required.
- Excellent oral and written communication as well as effective presentation skills is required.
- Demonstrated problem solving and conflict resolution are required.
- Programming experience in SAS and/or ‘R’.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SDTMADaMMacro ProgrammingSASRdata statistical programmingclinical data standard modelsdata standardizationdefine.xmlSDRG
Soft skills
project managementleadershipcollaborationattention to detailproblem solvingconflict resolutionoral communicationwritten communicationpresentation skillsability to manage priorities
Certifications
Bachelor’s Degree