Biostatistics Director (Hybrid) jobs in United States
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Vertex · 1 day ago

Biostatistics Director (Hybrid)

Vertex is a global biotechnology company that invests in scientific innovation. The Director, Biostatistics will independently perform highly scientific statistical functions in support of the company’s Global Medicines Development and Affairs area on new and complex issues, while managing a team and providing strategic input.

Computer Software
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H1B Sponsor Likelynote

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
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

Qualification

SASR statistical softwareAdvanced statistical methodsNDA/MAA experienceStaff managementProject managementCritical thinkingCommunication skillsTeam collaboration

Required

Ph. D. in Statistics or Biostatistics
Typically requires 10 years of experience with a Ph.D
Prior staff management experience
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

Benefits

Annual bonus
Annual equity awards
Overtime pay
Medical, dental and vision benefits
Generous paid time off
Educational assistance programs including student loan repayment
Generous commuting subsidy
Matching charitable donations
401(k)

Company

Vertex

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Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.

H1B Sponsorship

Vertex has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)

Funding

Current Stage
Early Stage
Company data provided by crunchbase