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Company

Original Job Post

Bristol Myers Squibb · 2 days ago

Director Biostatistics

Princeton, NJ

Full-time

Hybrid

Director

9+ years exp

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Responsibilities

Drives innovative and efficient study design. Develops study designs that address study objectives that will support regulatory approval and market access.

Contributes to the product development strategy including development of clinical development plans, leads GBDS-related submission activities, and post-submission strategies/ preparations/defenses.

Independently leads, initiates, and oversees the statistical support for the development of compounds. This includes providing guidance and management to statisticians, statistical programmers and data scientists supporting the asset to ensure high quality and timely deliverables.

Effectively engages as a matrix team member on high level development teams, to act as a scientific and strategic partner in the drug development process.

Presents and defends complex statistical solutions to all levels of BMS governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provide influence on key decisions. Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information.

Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable

Contributes to creation/maintenance of and provide training on statistical topics departmental SOPs.

Manages a functional or project budget and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards therein.

Represents BMS at professional societies, and in industry-wide technical discussions.

Contributes to the statistical community of practice

Provides active coaching to statistical team members when developing solutions to problems.

Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.

Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.

Effectively engages as an employee advocate and management coach/mentor to team members both internally and externally

Provides leadership to empower and develop the team.

Provides guidance to employee's development plans and carries out performance review and feedback. Develops performance metrics for staff.

Qualification

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Scientific computingProgrammingSASRPythonStatistical analysisData manipulationGraphingSimulationClinical trials methodologyRegulatory affairsGlobal regulatory agency interactionsWorkforce planningTalent managementStrategy developmentProblem-solvingInterpersonalCommunicationOrganizationalCollaborationLeadershipManagement Experience

Required

PhD (9+ years experience) or MS (11+ years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience

Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation

Excellent interpersonal, communication, writing and organizational skills

Demonstrate expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards

Experience in preparing and participating in global regulatory agency interactions

Demonstrate excellent collaboration, organizational/leadership abilities, and interpersonal skills

Demonstrate development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area

Preferred

At least 3 years management (direct or matrix) experience is preferred (for people manager position only)

Benefits

Health Insurance

Company

Bristol Myers Squibb

Glassdoor

3.8

At Bristol Myers Squibb, we work every day to transform patients’ lives through science.

Founded in 1887

New York, New York, USA

10,001+ employees

http://www.bms.com

H1B Sponsorship

Bristol Myers Squibb 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

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2021 (1)