Bristol Myers Squibb Company

Associate Director, Clinical Data Standards

Location
Celgene, NJ, United States
Posted
Sep 13, 2020
Ref
R1526672
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
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.

Division

Research and Development (R&D), Global Clinical Operations (GCO), Global Data Management and Centralized Monitoring (GDMCM)

Functional Area Description

Global Data Management and Centralized Monitoring is responsible for clinical trial data acquisition, quality review, and standards governance for trials across the BMS R&D portfolio.

Position Summary / Objective

The Global Clinical Standards Specialist is a role with oversight of the standardization of data collection instruments and directly contributes to the BMS R&D pipeline.

This role reports to the Associate Director, Global Standards Team Lead within Clinical Data Acquisition and Standards

Position Responsibilities

Responsibilities include:
  • Develop and maintain existing standards used in support of Immuno- Oncology trials managed internally and by external partners.
  • Partner with functional area stewards to establish and maintain processes for ensuring alignment across the data chain and associated systems.
  • Evaluate industry best practices in the areas of study and data management, data tabulation and analysis & reporting, and identify standardization development or improvement opportunities.
  • Provide recommendations on changes or new standards to data chain co-chairs taking into account various stakeholder needs while ensure regulatory and BMS best practices are followed.

Degree Requirements

Minimum of Bachelor's degree

Experience Requirements

5-10 years of experience in pharmaceutical industry of which 5 years have been in Clinical Data Management and/or Analysis & Reporting areas.

Key Competency Requirements

Competency Requirements include:
  • Experience in the management of clinical trials including startup, conduct, and reporting activities.
  • Experience in Industry Standards (e.g. CDISC) in either the collection (CDASH), tabulation (SDTM) or analysis (ADaM) models.
  • Experience interpreting Health Authority regulations with a strong compliance background.
  • Broad experience in various clinical database tools and applications for data collection, review, and the production of tables, listings, and graphs.
  • Knowledge of data integration strategies and practices in support of external partnerships, strategic sourcing, and third party data acquisition.
  • Demonstrated ability to lead high-performing multidisciplinary teams and build alignment across functional areas for both drug programs and continuous improvement projects.
  • Skilled in project planning and management including resourcing, risk assessment, crisis management, and timeline projections.
  • Strong negotiation and collaboration skills with ability to drive resolution of complex issues.
  • Experience with Medidata Rave is a plus.


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.