Executive Director, Biostatistics

Vertex Inc. • Boston, MA

2d • Hybrid

About The Position

General Summary: The Senior Director, Biostatistics will independently perform highly scientific statistical functions in support of a company therapeutic area or areas on new and complex issues. The incumbent will complete work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results if needed. In addition, the Senior Director provides independent strategic and technical contributions. The incumbent should possess an excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff. Key Duties and Responsibilities: Defines and implements the technical and strategic direction of assigned area of responsibility, guiding technological innovation and process improvements aligned to 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.

Requirements

• 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
• Profound abilities in critical thinking and logical problem-solving
• Highly-developed written and verbal communication skills with the ability to influence opinions of peers and managers, overcome objections and negotiate with others to adopt a different point of view
• Expertise in collaborating with non-statisticians and explaining highly complex concepts to non-technical audiences
• Ph. D. or master's degree in Statistics or Biostatistics.
• Typically requires 12 years of experience with a Ph.D. or 15 years of experience with a master's degree, or the equivalent combination of education and experience.

Responsibilities

• Defines and implements the technical and strategic direction of assigned area of responsibility, guiding technological innovation and process improvements aligned to 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

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• 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: Executive
• Education Level: Ph.D. or professional degree