Biogen · 2 days ago
Sr Principal Analyst, Statistical Programming
United States
Full-time
Remote
Senior Level, Lead/Staff
$134K/yr - $179K/yr
8+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. The Senior Principal Analyst, Statistical Programming is responsible for leading the management of SDTM operating activities and collaborating cross-functionally to implement best practices in data standardization and quality oversight.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
The candidate will work very closely with SDTM Leads and ensure high quality study deliverables are in a timely manner
Oversight of vendor/FSP resources workload and quality measurement. Serves as first line for in SDTM escalation pathway
ADaM Standards Development and Maintenance
Develop, maintain, and enhance ADaM standards, ensuring alignment with CDISC ADaM Implementation Guide (ADaMIG) versions, evolving regulatory guidance, and company needs
Create and maintain ADaM dataset specifications, including metadata templates, controlled terminology, and traceability documentation
Serve as the primary point of contact for ADaM standards-related questions, guidance, and implementation best practices
Contribute toward Standard TFL Development and Maintenance
Collaborate with statistical programming and biostatistics teams to ensure standard TFLs align with ADaM dataset design and analysis requirements
Provide guidance on TFL best practices, including automation strategies and standardization approaches
Participate in Data Standards Governance activities to ensure consistency and quality with study level ADaM implementation
Training and Knowledge Sharing
Develop and deliver training materials, workshops, and documentation to educate teams on ADaM standards, standard TFLs, and implementation strategies
Support internal stakeholders with expertise in ADaM dataset design, structure, and programming best practices
Participate on the CDISC Analysis Data Model Team to ensure continued education and awareness of evolving ADaM standards and that Biogen is part of the active CDISC ADaM community to enable escalation of internal questions to a network of industry ADaM professionals
Participates in external initiatives to proactively adopt industry trends and anticipate regulatory needs
Qualification
Required
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
Pharmaceutical Technology
2026-01-05
thecanadianpressnews.ca
2025-12-24
Company data provided by crunchbase