Director, Statistical Programming
About The Position
The Director of Statistical Programming heads the Global Submissions group within Statistical Programming, Digital and Data Science (SPDDS), overseeing strategy, planning, and execution of global regulatory submissions across the portfolio. The role allocates resources to meet program and therapeutic-area submission milestones, partners across departments to align strategies, and maintains high-quality standards. The Director shapes operational and sourcing strategies for submission-related statistical programming activities, strengthens cross-functional partnerships, and improves internal processes. The role supports drug programs and development sciences through best practices and innovation, while coaching, influencing, and advocating for the team and fostering excellence and continuous improvement.
Requirements
- Bachelor’s degree required.
- 12+ years of relevant work experience in statistical programming and analysis.
- 12+ years of SAS Base programming experience, with 7+ years using SAS STAT, GRAPH, and MACRO.
- 12+ years of relevant industry experience and clinical trial experience.
- 7+ years in a supervisory (managerial) role.
- Extensive hands-on experience working on and leading global regulatory submissions from the sponsor side.
- Extensive and up-to-date knowledge of regulatory requirements and global submission guidelines.
- Strong management and leadership skills, with the ability to lead cross-functional teams.
- Proven ability to manage multiple priorities and drive process improvements.
- Excellent written and oral communication skills.
Nice To Haves
- Master’s or PhD in Statistics or Mathematics.
- Experience with strategic change management within a large cross-functional initiative.
- Strong skills in compelling communication, driving execution, and cultivating networks.
Responsibilities
- Develop and implement operational and sourcing strategies for global submissions within statistical programming.
- Develop and influence global submission planning and timelines.
- Ensure timely execution of statistical programming and electronic submission activities across all drug programs.
- Identify opportunities for technical and process improvements and drive implementation.
- Develop and oversee programming standards, conventions, and efficient procedures.
- Provide leadership in talent acquisition, retention, and development within the department.
- Collaborate with cross-functional teams to align strategies and ensure optimal data delivery and analysis.
- Manage resources and budgets effectively to meet program goals.
- Stay updated on regulatory requirements and trends to ensure compliance.
- Promote a culture of innovation and continuous improvement within the team.
- Coach, influence, and advocate for the team.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Fitness and wellness programs, including fitness reimbursement
- Short- and long-term disability insurance
- At least 15 days of paid vacation
- Additional end-of-year shutdown time off from December 26 to December 31
- Up to 12 company-paid holidays
- Three paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid maternity and parental leave
- 401(k) program with company-matched contributions
- Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation
- Short-term and long-term incentives, including cash bonus and equity incentive opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Director
