Alkermes · 1 day ago
Senior Director, Statistical Programming
Greater Boston
Full-time
Onsite
Director/Executive
$225K/yr - $239K/yr
15+ years expAlkermes is a fully-integrated, global biopharmaceutical company focused on developing medicines for complex psychiatric and neurological disorders. The Senior Director, Statistical Programming will lead the statistical programming team, ensuring high-quality deliverables and compliance with regulatory standards while contributing to strategic planning and resource management.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Develop and lead a team of high performing statistical programmers to meet corporate regulatory, scientific, and business objectives. Deliveries of the statistical programming group includes ADaM specifications and datasets, TLFs and data submission documents
Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
Establish and maintain efficient statistical programming processes and high quality standards
Ensure CDISC standards, regulatory expectations, and quality requirements are met across all deliverables
Ability to guide and contribute to complex programming efforts
Effectively coordinate statistical programming activities with outside organizations, CROs and consultants
Participate in establishment and development of department SOPs
Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
Maintain an active role in planning and preparation of regulatory submissions
Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Operations management
Work with IT to develop and maintain programming environment to ensure data security and efficient analysis and reporting
Qualification
Required
Advanced degree (MS or above) in statistics, computer science or related fields with strong analytical skills
15+ years of experience in pharma/biotech and/or CRO setting
Demonstrated people management and resource planning experience
Preferred
Proven expert in SAS programming and analytical skills using BASE SAS, SAS/STAT, SAS/GRAPH and SAS MACROS etc
Extensive CDISC SDTM and ADaM knowledge with significant experience writing ADaM specifications using robust and detailed instructions
Strong hands-on SAS programming skills for clinical trial reporting
Experience with electronic FDA submission
Proficiency in other data analysis programming languages, such as R and Python preferred
Ability to learn new programming language quickly and be motivated to utilize them in the clinical development field
Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
Strong interpersonal, organizational, and multi-tasking skills
Excellent attention to detail and problem-solving skills
Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
Effective communicator, both written and oral, who can explain complex technical concepts to non‑technical stakeholders
Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
Neuroscience experience is a plus
SAS LSAF experience is a plus
Flexible to changing priorities, detail-oriented, works well under pressure
Demonstrate vision for leading the statistical programming group and track record of executing the vision
Benefits
Annual performance pay bonus
Competitive benefits package
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes 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 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-20
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2026-01-16
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