Summary

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.

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.

Requirements

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

Benefits

Medical, Dental & Vision
Life Insurance
Fitness & Wellness Programs
Short- & Long-Term Disability
Paid Vacation
Paid Holidays
Paid Maternity & Parental Leave
401(k) Matching
Employee Stock Purchase Plan
Tuition Reimbursement
Employee Resource Groups

Company overview

Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.