Director, Biostatistics

Vertex Inc.•Boston, MA

3d•$204,000 - $306,000•Hybrid

About The Position

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 possess 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.

Requirements

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.

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.
Manage a team of direct reports including their performance and development. Mentors project team members and promotes effective team operation and cross-functional collaboration.
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.