Associate Director, Biostatistics

Bristol Myers Squibb•Madison, WI

About The Position

The Associate Director of Biostatistics is a member of cross-functional Development teams and contributes to clinical trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, this role may support a particular indication of an asset and works collaboratively with the Biostatistics indication/asset Lead and other cross-functional team members. The role applies statistical and clinical-trial methodology throughout clinical development, supports multiple studies within an indication or therapeutic area, and contributes to project strategy and the broader statistical community. People-manager responsibilities, where applicable, include coaching and developing team members, supporting performance reviews and development plans, and establishing staff performance metrics.

Requirements

  • PhD with at least 6 years of experience, or MS with at least 8 years of experience, in statistics, biostatistics, or a related scientific field.
  • Experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
  • Proficiency in scientific computing/programming using SAS, R, or Python, including advanced statistical analysis, data manipulation, graphing, and simulation.
  • Strong interpersonal, communication, writing, and organizational skills.
  • Expertise in statistical and clinical-trial methodology as it relates to clinical development, and ability to apply it within a relevant clinical-development framework.
  • Good understanding of the regulatory landscape and experience participating in regulatory interactions.
  • Collaboration, organizational and leadership abilities, and interpersonal skills.
  • Ability to plan, organize, and prioritize multiple work assignments, with strong project-management skills.

Nice To Haves

  • People-manager experience is preferred for people-manager positions.

Responsibilities

  • Collaborate on innovative and efficient clinical trial design, including selecting study populations and endpoints to address study objectives, and contribute to project development strategy.
  • Defend protocols and analysis plans at internal governance reviews and independently review complex protocols.
  • Independently author and/or review protocols, statistical analysis plans, clinical study reports, publications, and other study-level documents.
  • Present summary data and analysis results clearly, concisely, completely, and transparently.
  • Provide statistical support and leadership for health authority requests, publications, presentations, and other public releases of information.
  • Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area.
  • Apply statistical and clinical-trial methodology to clinical development.
  • Develop knowledge beyond traditional statistical expertise, including in clinical, regulatory, and commercial environments, and apply it to study design.
  • Engage effectively as a matrix team member and scientific and strategic partner in drug development.
  • Follow BMS processes and SOPs, adhere to global and project standards, and ensure the quality of deliverables.
  • Contribute to the internal and external statistical community of practice.
  • Develop and advise team members.
  • Communicate the DQS Mission and Vision in a way that generates pride, excitement, and commitment within DQS.
  • For people managers: serve as an employee advocate and management coach or mentor; empower and develop the team; guide employee development plans; conduct performance reviews and provide feedback; and develop staff performance metrics.

Benefits

  • Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
  • Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
  • Paid company holidays; some employee groups are also eligible for optional holidays and annual paid vacation.
  • Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
  • Eligible employees may participate in an annual Global Shutdown between Christmas Day and New Year's Day.
  • Potential eligibility for discretionary cash incentives and stock opportunities.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Ph.D. or professional degree

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