Biostatistics Associate Director

Vertex Inc.•Boston, MA

6d•$236,000 - $354,000•Hybrid

About The Position

General Summary: The Associate Director, Biostatistics will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. The incumbent will completed work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent is capable of independent strategic and technical contributions. The incumbent should possess a good 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: •Conducts all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations. •Leads biostatistics projects or major components of a project including work allocation and review. •May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards. •Manages one or more team members, including their performance and development. •Possesses an advanced and in-depth understanding of modern drug discovery and development processes. •Represents Biostatistics as a member of cross functional teams, providing input and specialized technical guidance to elicit meaningful and/or productive outcomes. •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) in order to facilitate the review, summary, and dissemination of key study data/results. •Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality. •Contributes to clinical study reports (CSRs) and related processes, authoring or co-authoring methodological or study-related publications and posters. •Provides input into programming specifications and review. •Contributes to external interactions with regulators, payers, review boards, etc. •Authors or co-authors methodological or study-related publications and posters. •Determines and implements design 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 various advanced technical and operational issues. •Independently undertakes new and complex issues. •Completes assigned work in a resourceful, self-sufficient manner, often conceptualizing alternative approaches to achieve desired results. •Develops breadth of knowledge across related disciplines with a drug developer mindset.

Requirements

Some prior staff management experience is typical
In-depth competence with SAS and R statistical software
In-depth understanding of advanced statistical methods used in drug development
Ability to show critical thinking with logical problem-solving
Excellent written and verbal communication skills
Excels in a team environment
Collaborates well with non-statisticians
NDA/MAA experience and direct dealings with USA/European regulators
Typically requires 7 years of experience with a Ph.D. or 10 years of experience with a master's degree, or the equivalent combination of education and experience
Ph. D. or master's degree in Statistics or Biostatistics.

Responsibilities

Conducts all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations.
Leads biostatistics projects or major components of a project including work allocation and review.
May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
Manages one or more team members, including their performance and development.
Possesses an advanced and in-depth understanding of modern drug discovery and development processes.
Represents Biostatistics as a member of cross functional teams, providing input and specialized technical guidance to elicit meaningful and/or productive outcomes.
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) in order to facilitate the review, summary, and dissemination of key study data/results.
Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
Contributes to clinical study reports (CSRs) and related processes, authoring or co-authoring methodological or study-related publications and posters.
Provides input into programming specifications and review.
Contributes to external interactions with regulators, payers, review boards, etc.
Authors or co-authors methodological or study-related publications and posters.
Determines and implements design 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 various advanced technical and operational issues.
Independently undertakes new and complex issues.
Completes assigned work in a resourceful, self-sufficient manner, often conceptualizing alternative approaches to achieve desired results.
Develops breadth of knowledge across related disciplines with a drug developer mindset.

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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume