Director, Statistical Programming

TalentAlly; Cambridge (MA); On-site; USD 209,000 - 288,000; Full time

Benefits offered by this job

Medical/Dental/Vision/Life insurance

Fitness & Wellness programs

Disability insurance

Paid vacation & holidays

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen in Cambridge, MA seeks a Director of Statistical Programming to lead the Global Submissions group, shaping strategy and execution for global regulatory submissions across portfolios. You will allocate resources, align cross-functional plans, and maintain high-quality standards to advance development programs.

The role requires deep regulatory knowledge, SAS expertise, and a track record of leading sponsor-side submissions.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 13+ years in statistical programming and analysis with leadership experience.
• Extensive regulatory submission experience from sponsor side.

Responsibilities

• Develop and implement global submission strategies within statistical programming.
• Influence global submission planning and timelines across programs.
• Ensure timely execution of programming for regulatory submissions.
• Identify and drive process and technical improvements.
• Develop programming standards and efficient procedures.
• Provide leadership in talent acquisition, retention, and development.
• Collaborate with cross-functional teams to align data delivery and analyses.
• Manage resources and budgets to meet program goals.
• Stay updated on regulatory requirements and submission guidelines.
• Promote innovation and continuous improvement within the team.

Skills

SAS Base

SAS Stat/Graph/Macro

Regulatory submissions

Leadership

Cross-functional

Regulatory knowledge

Strategic planning

Education

Bachelor's degree

Master's or PhD in Statistics or Mathematics

Job description

About This Role

As Director of Statistical Programming within Statistical Programming, Digital and Data Science (SPDDS), you will head the Global Submissions group, overseeing strategy, planning, and execution of global regulatory submissions across the portfolio. You will allocate resources to meet program and therapeutic area submission milestones, partner across departments to align strategies, and maintain high-quality standards. You will shape operational strategies for submission-related statistical programming activities, strengthen cross-functional partnerships, and improve internal processes. Through best practices and innovation, you will support the success of our drug programs and advance development sciences. As a senior leader, you will coach, influence, and advocate for your team, fostering excellence and continuous improvement.

What You'll Do

• 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.

Who You Are

You are a visionary leader with a strategic mindset and a passion for driving excellence in statistical programming. Your strong collaboration skills enable you to build effective partnerships and influence without authority. You possess a deep understanding of regulatory requirements and a commitment to maintaining high-quality standards. Your ability to manage complex projects and navigate cross-functional initiatives makes you an asset to any team. You thrive in a dynamic environment where you can inspire and develop others to achieve their full potential.

Required Skills

• Bachelor's degree required; Masters or PhD in Statistics or Mathematics preferred.
• 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 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.

Preferred Skills

• Experience with strategic change management within a large cross-functional initiative.
• Strong skills in compelling communication, driving execution, and cultivating networks.

Job Level

Management

Additional Information

The base compensation range for this role is: $209,000.00-$287,750.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid‑sized biotechnology company, we provide the stability and resources of a well‑established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life‑changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read onto learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E‑Verify Employer in the United States.

VEVRAA Federal Contractor.

We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.

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