Director, Biostatistics

Vertex Inc. • Boston, MA

3d • $204,000 - $306,000 • Hybrid

About The Position

The Director, Biostatistics independently performs highly scientific statistical work supporting Vertex’s Global Medicines Development and Affairs (GMDA) area, including work on new and complex issues. The role makes independent strategic and technical contributions, applies an expert understanding of related disciplines and modern drug development, and develops resourceful approaches to achieve desired outcomes. As a people manager, the Director has financial accountabilities and human resource responsibilities for assigned staff.

The Director leads one or more projects that may span multiple clinical trials, observational studies, or real-world data investigations. The role represents Biostatistics on cross-functional teams, provides strategic and expert technical guidance, and sets project scientific and technical direction. It also leads and develops direct reports, mentors project members, and promotes effective collaboration.

The position develops statistical plans and study deliverables, partners with statistical programming on high-quality outputs, participates in external interactions, and authors or co-authors publications and posters. The Director also contributes to methodological innovation, departmental working groups, and review forums.

Requirements

• Ph.D. or master's degree in Statistics or Biostatistics.
• Typically, 10 years of experience with a Ph.D. or 13 years with a master's degree, or an equivalent combination of education and experience.
• Project management and project team oversight skills.
• Expertise with SAS and R statistical software.
• Demonstrated expertise in advanced or complex statistical methods used in drug development.
• Strong critical thinking and logical problem-solving skills.
• Excellent written and verbal communication skills, including the ability to influence peers and managers.
• Ability to work effectively in a team environment and collaborate with non-statisticians, explaining complex concepts to non-technical audiences.
• NDA/MAA experience and direct dealings with U.S. and European regulators.

Responsibilities

• Direct one or more projects involving multiple clinical trials, observational studies, or real-world data investigations, including presentations to the Peer Protocol Review Committee or other internal senior review boards.
• Manage direct reports, including their performance and development.
• Mentor project team members and promote effective team operation and cross-functional collaboration.
• Represent Biostatistics on cross-functional teams, providing strategic input and expert technical guidance and setting project technical and scientific direction.
• Author study Statistical Analysis Plans, including table, figure, and listing shells.
• Develop Cross-functional Data Review plans, Key Reports Memos, and Data Dissemination Plans to facilitate review, summary, and dissemination of study data and results.
• Lead collaboration with statistical programming and other functions to ensure high-quality, technically sound delivery of tables, figures, and listings.
• Lead or contribute to external interactions with regulators, payers, review boards, and other parties.
• Author or co-author methodological or study-related publications and posters.
• Lead implementation of innovative designs and analysis methods at the study or project level.
• Participate in Statistical Review Forum discussions of studies assigned to others.
• Contribute to departmental working groups addressing technical and operational issues.
• Independently address new and highly complex issues requiring advanced analytical thought, using resourceful and self-sufficient approaches.

Benefits

• Annual bonus and annual equity awards; some roles may also be eligible for overtime pay in accordance with federal and state requirements.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy.
• Matching charitable donations.
• 401(k).
• Other benefits and resources supporting employees’ financial, family, and wellbeing needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director