Associate Director – Biostatistics

Role Overview

• Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy
• Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols.
• Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
• Presents summary data and analyses results, in a clear, concise, complete, and transparent manner
• Provides statistical support and leadership to address health authority requests, publication, presentation, and other public releases of information
• Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
• Applies extensive knowledge of statistical/clinical trials methodology as it relates to clinical development
• Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design.
• Effectively engages as a matrix team member on project teams, acting as a scientific and strategic partner in the drug development process
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverables
• Contributes to external and internal statistical community of practice
• Develops & advises team members
• Effectively communicates the DQS Mission and Vision in a fashion that generates pride, excitement and commitment within DQS.
• 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 employees' development plans and carries out performance reviews and feedback. Develops performance metrics for staff.

Requirements

• PhD (6+ years’ experience) or MS (8+ 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.
• Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework
• Good understanding of regulatory landscape and experience with participating in regulatory interactions
• Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills
• Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills
• People manager experience is preferred (for people manager position only)

Tech Stack

• Python

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short
• and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.