General Summary
The Director, Biostatistics will independently perform highly scientific statistical functions in support of the company's Global Medicines Development and Affairs (GMDA) area 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 Director provides independent strategic and technical contributions. The incumbent possesses an excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. As a people manager within the organization, has financial accountabilities and human resource responsibilities for assigned staff.
Key Duties and Responsibilities
•Directs one or more projects including multiple clinical trials, observational studies, or real world data (RWD) investigations. Also includes presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
•Manages a team of direct reports including their performance and development. Mentors project team members and promotes effective team operation and cross-functional collaboration.
•Possesses an expert understanding of modern drug discovery and development processes.
•Represents Biostatistics as a member of cross functional teams, providing strategic input and expert technical guidance to elicit meaningful and/or productive outcomes. Sets the technical and scientific directions of the project(s).
•Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results.
•Leads collaboration with statistical programming and other functions to ensure high quality and technically sound delivery of TFLs.
•Leads or contributes to external interactions with regulators, payers, review boards, etc.
•Authors or co-authors methodological or study-related publications and posters.
•Leads implementation of innovative designs and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
•Contributes to departmental working group efforts on key various technical and operational issues.
•Independently undertakes new and highly complex issues requiring advanced analytical thought.
•Completes work in a resourceful, self-sufficient manner; conceptualizes alternative, and at times untested, approaches to achieve desired results.
•Maintains and expands in-depth knowledge of related disciplines with a drug developer mindset.
Knowledge and Skills
•Project management and project team oversight
•Expertise with SAS and R statistical software
•Demonstrated expertise in advanced/complex statistical methods used in drug development
•Deep skill in critical thinking and logical problem-solving
•Excellent written and verbal communication skills with the ability to influence opinions of peers and managers
•Excels in a team environment
•Collaborates well with non-statisticians and can effectively explain complex concepts to non-technical audiences
•NDA/MAA experience and direct dealings with USA/European regulators
Education and Experience
•Ph.D. or master's degree in Statistics or Biostatistics
•Typically requires 10 years of experience with a Ph.D. or 13 years of experience with a master's degree, or the equivalent combination of education and experience
Pay Range
$204,000 - $306,000. The range provided is based on what is believed to be a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
Total Rewards offerings also include inclusive market-leading benefits: medical, dental and vision benefits, 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 more.
Flex Designation
Hybrid-Eligible Or On-Site Eligible. In this Hybrid-Eligible role, you can choose to be designated as:
1.Hybrid: work remotely up to two days per week; or
2.On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
