Senior Director, Biostatistics (Hybrid)

Vertex Pharmaceuticals • Boston, MA

1d • Hybrid

About The Position

As a Sr. Director Biostatistics, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may leads to medical breakthroughs You will collaborate with interdisciplinary teams, applying novel statistical methodologies to solve real-world challenges, ultimately contributing to the development of life-saving treatment and improving global well-being. You will be responsible for leadership of a team to plan and execute strategy for this novel therapeutic space from a statistical point of view. The Senior Director, Biostatistics will lead and perform highly scientific statistical functions in support of a company Therapeutic Area, as well as new and complex innovative issues. The Senior Director drives breakthrough results with strategic and technical contributions, while possessing an excellent knowledge of Biostatistics with a drug developer mindset. As a senior leader and people manager within the organization, they will play a crucial role in culture creation, team building, and coaching to direct reports and junior employees across the organization.

Requirements

• Ph. D. in Statistics or Biostatistics.
• Typically requires 12 years of experience with a Ph.D. or the equivalent combination of education and experience.
• Prior people management experience required
• Previous project/process leadership experience required
• NDA/MAA experience and direct dealings with US or European regulators
• Significant expertise with SAS and R statistical software
• Demonstrated expertise in advanced/complex statistical methods used in drug development

Responsibilities

• Defines and implements the technical and strategic direction of assigned area of responsibility, guiding technological innovation and process improvements aligned to Biostatistics Functional/Departmental objectives.
• Oversees, manages, and directs multiple key projects, providing both strategic and technical expertise, and including clinical trials, observational studies, real world data (RWD) investigations, or other scientific research.
• Contributes to drug development strategy including clinical development plans and lifecycle management planning documents.
• Develops technical leadership, guides project teams to more meaningful and/or productive ends. Sets the technical and scientific directions of the project(s).
• Oversees the delivery of KRMs, conducts senior review of protocols, CSRs, publications, and statistics related documents for regulatory interaction, and approves SAPs.
• Contributes or oversees the statistical contributions to external interactions with regulators, payers, review boards, etc.
• Key contributor to Statistical Review Forum (SRF) to enable statistical excellence and Biometrics strategic input in study design and planning.
• Authors or co-authors methodological or study-related publications and posters.
• Leads or oversees development and implementation of innovative designs and analysis methods.
• Oversees or contributes in a leading role to departmental working group efforts on various technical and operational issues.
• Oversees the performance of project team members, ensuring proper level of scientific rigor, effective team operation and cross-functional collaboration.
• May contribute to the management of the biostatistics department as a member of the departmental senior leadership team.
• Represents Biostatistics at leadership meetings and senior management reviews.

Benefits

• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees