Senior Director Evidence Delivery
About The Position
About This Role The Senior Director, Evidence Delivery leads a global organization responsible for transforming clinical data into high-quality, actionable evidence across the clinical development portfolio. This role drives the strategy, innovation, and operational excellence behind submission-ready datasets, analyses, and visualizations that support regulatory, market access, and publication needs. The Senior Director champions modernization through open-source programming, advanced analytics, automation, and AI/ML. Reporting within SPDDS and QSDO, this leader ensures regulatory compliance, inspection readiness, and continuous improvement while building a future-ready evidence delivery organization. What You’ll Do Define and execute the global Evidence Delivery strategy aligned with clinical development and regulatory objectives Lead delivery of high-quality, submission-ready datasets, analyses, and visualizations Drive adoption of open-source programming platforms such as R and Python Champion AI/ML, automation, and advanced analytics to improve efficiency and scalability Establish reproducibility, transparency, and traceability frameworks for evidence generation Ensure compliance with SOPs, GCP, CDISC standards, and regulatory requirements Lead modernization initiatives including cloud computing and workflow automation Partner cross-functionally with Statistics, CDM, Regulatory, Safety, Digital, and Market Access teams Build, mentor, and retain a high-performing global evidence delivery organization Represent Evidence Delivery in audits, inspections, and external industry forums Who You Are You are a visionary evidence and analytics leader who thrives in regulated environments and complex global organizations. You combine deep technical expertise with strategic thinking, innovation, and people leadership to deliver high-impact clinical evidence.
Requirements
- Advanced degree in Statistics, Data Science, Computer Science, or related field
- 15+ years experience in biotech, pharma, CRO, or clinical development environments
- Senior leadership experience in evidence generation or statistical programming
- Deep expertise in SAS and strong knowledge of CDISC standards
- Strong understanding of clinical trial processes and regulatory requirements
- Proven success leading teams in regulated environments
- Experience implementing automation and advanced analytics solutions
- Exceptional stakeholder engagement and communication skills
Nice To Haves
- Experience applying AI/ML in clinical evidence workflows
- Management of external service providers and strategic technology partners
Responsibilities
- Define and execute the global Evidence Delivery strategy aligned with clinical development and regulatory objectives
- Lead delivery of high-quality, submission-ready datasets, analyses, and visualizations
- Drive adoption of open-source programming platforms such as R and Python
- Champion AI/ML, automation, and advanced analytics to improve efficiency and scalability
- Establish reproducibility, transparency, and traceability frameworks for evidence generation
- Ensure compliance with SOPs, GCP, CDISC standards, and regulatory requirements
- Lead modernization initiatives including cloud computing and workflow automation
- Partner cross-functionally with Statistics, CDM, Regulatory, Safety, Digital, and Market Access teams
- Build, mentor, and retain a high-performing global evidence delivery organization
- Represent Evidence Delivery in audits, inspections, and external industry forums
Benefits
- Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
- In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
