Director of Global Submissions & Statistical Programming

Biogen; North Carolina; On-site; USD 209,000 - 288,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life ins.

Retirement plan with company match

Stock purchase plan

Tuition reimbursement

Paid time off and holidays

Wellness programs

Job summary

Biogen in North Carolina seeks a Director of Statistical Programming to lead the Global Submissions group within SPDDS. You will shape strategies, allocate resources, and ensure timely, high-quality regulatory submissions across the portfolio.

As a senior leader, you will coach teams, drive process improvements, stay current with regulatory guidelines, and partner across functions to deliver data-driven decisions that advance development programs and patient outcomes.

Qualifications

• 12+ years in statistical programming and analysis.
• Extensive hands-on experience with global regulatory submissions from sponsor side.
• Strong knowledge of regulatory requirements and submission guidelines.

Responsibilities

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

Skills

SAS Base

SAS STAT

SAS GRAPH

SAS MACRO

Regulatory submissions

Leadership

Team management

Budget management

Cross-functional collaboration

Communication skills

Education

Bachelor's degree

Master's or PhD in Statistics or Mathematics

Tools

SAS

Job description

Biogen in North Carolina seeks a Director of Statistical Programming to lead the Global Submissions group within SPDDS. You will shape strategies, allocate resources, and ensure timely, high-quality regulatory submissions across the portfolio.

As a senior leader, you will coach teams, drive process improvements, stay current with regulatory guidelines, and partner across functions to deliver data-driven decisions that advance development programs and patient outcomes.