Director of Global Submissions & Statistical Programming

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

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Vacation & holidays

Job summary

Biogen seeks a Director of Statistical Programming to lead the Global Submissions group within SPDDS. You will shape strategy, plan timelines, allocate resources, and ensure high-quality submissions across the portfolio.

The role requires senior leadership, coaching, and building strong cross-functional partnerships to accelerate drug development. You will drive process improvements, stay current with regulatory guidelines, and guide teams through complex sponsor submissions, contributing to

Qualifications

• 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.

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.

Skills

Strategic leadership

Statistical programming

SAS Base

SAS Macro

SAS Graph

Regulatory submissions

Cross-functional collaboration

Communication

Budget & resources

Team leadership

Education

Bachelor’s degree

Masters or PhD in Statistics or Mathematics

Tools

SAS Base

SAS STAT

SAS GRAPH

SAS MACRO

Job description

Biogen seeks a Director of Statistical Programming to lead the Global Submissions group within SPDDS. You will shape strategy, plan timelines, allocate resources, and ensure high-quality submissions across the portfolio.

The role requires senior leadership, coaching, and building strong cross-functional partnerships to accelerate drug development. You will drive process improvements, stay current with regulatory guidelines, and guide teams through complex sponsor submissions, contributing to