Director, Statistical Programming

Biogen•Cambridge, MA

About The Position

The Director of Statistical Programming within Statistical Programming, Digital and Data Science (SPDDS) leads the Global Submissions group and oversees 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 develops programming standards and procedures, supports drug-program success and development sciences through best practices and innovation, and leads talent acquisition, retention, and development. As a senior leader, the Director coaches and advocates for the team while 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, including 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, including 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 drug programs.
Identify opportunities for technical and process improvements and drive their 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 to meet program goals.
Stay updated on regulatory requirements and trends to ensure compliance.
Promote innovation and continuous improvement within the team.
Coach, influence, and advocate for the team.

Benefits

Short- and long-term incentives, including cash bonus and equity incentive opportunities.
Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
A minimum of 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 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 of up to $10,000 per calendar year.
Employee Resource Groups participation.