Bristol Myers Squibb Company

Principal Biostatistician

Location
Princeton, NJ, United States
Posted
Sep 12, 2020
Ref
R1528645
Required Education
Doctorate/PHD/MD
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Summary

The principal biostatistician is a member of cross-functional development teams and contributes to trial design, protocol developments, analysis planning, interpretation of results, and preparation of regulatory submission. Statisticians develop collaborative relationships and work effectively with the Biostatistics Lead, the Planning and Execution Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.

Direct Reports

None

Key Business Partners

Hematology/Oncology/Cell Therapy Early Clinical Development, Early Development Program Leadership

Detailed Position Responsibilities
  • Actively provide statistical support to the Early Clinical Development (Phase 1, 2a, Proof of Concept studies).
  • Provide statistical leadership into the design of protocols including preparation of the biostatistical analysis section. Suggest optimal statistical designs and dose escalation methods that are acceptable by regulators.
  • Serve as statistical lead on studies, or projects. Prepare statistical analysis plans including table shells. Analyze and report results of clinical trials. Provide ad hoc/data driven analyses.
  • Provide statistical input for the preparation of final study reports and other required documents.
  • Provide statistical support for integrated reports, submissions preparation, and post- submission activities.
  • Contribute to Clinical Development Plan.
  • Support preparation of manuscripts.
  • Provide project requirements to programmers.
  • Represent BMS in interfaces with regulatory agencies globally.
  • Provide statistical input to senior management.
  • Manage outside CROs and consultants as needed. Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.
  • May provide coaching and mentoring and provides feedback via formal/informal appraisals


Desired Experience

Required:
  • Ph.D. in statistics or biostatistics with a focus on statistical methods appropriate for clinical trials.
  • Relevant experience in clinical drug development of at least 5 years
  • Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel.
  • Demonstrated skills in the planning, analysis and reporting of clinical trials.
  • Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies.
  • Excellent SAS and R skills. Willingness to be hands-on when needed.
  • Knowledge of MS Office products (Word, Excel, PowerPoint)
  • Good interpersonal, communication, writing and organizational skills.
  • Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers.


Ideal Candidates Would Also Have:
  • Familiar with Bayesian methodology
  • Familiar with design and analysis of clinical trials in early phase oncology
  • Familiar with SDTM/ADaM


Development Value

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.