Director, Global Submissions & 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

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.