Bristol Myers Squibb Company

Principal Statistical Programmer

Location
Celgene, NJ, United States
Posted
Sep 11, 2020
Ref
R1526247
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.

Responsibilities will include, but are not limited to, the following:
  • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
  • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
  • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
  • Perform programming validation to ensure the quality of analysis datasets and programming outputs.
  • Ensure consistency and adherence to standards within the project.
  • Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
  • Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.
  • Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
  • Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
  • Serve as the lead programmer in support of NDAs, sNDAs.
  • Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables.
  • Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
  • Contribute to the creation, maintenance, and validation of standards for outputs and macros.
  • Provide training on SOPs, WPs and standard programs.
  • Contribute to the creation of naming conventions and development of the programming environment.
  • Oversee the services provided by CROs.


Skills/Knowledge Required:
  • Bachelor's Degree in life science, statistics, mathematics, computer science, or related field is required; Master's Degree is preferred.
  • 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions.
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
  • Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
  • Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
  • Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
  • Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
  • In-depth understanding of regulatory, industry, and technology standards and requirements.
  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
  • Demonstrated ability to work in a team environment with clinical team members.
  • Good planning and project management skills.
  • Good interpersonal, communication, writing and organizational skills.


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.