Bristol Myers Squibb

Senior Manager, Statistical Programming

2 months agoSeattle, WA

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.

PREREQUISITES

  • Bachelor's degree with 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions; or 8 plus years experience with a MS/MA degree.
  • 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.

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.
  • Ensure consistency and adherence to standards within their therapeutic area.
  • 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.
  • Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
  • Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
  • Serve as the lead programmer in support of NDAs, sNDAs.
  • Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
  • Provide training on departmental SOPs/WPs and standard programs.
  • Contribute to the creation of naming conventions and standards for the programming environment.
  • Routinely interface with cross-functional team members.
  • Influences other functions and represents as DOP technical expertise.
  • Represent as internal team leader who decides best course of action.
  • Coach and advise junior programmers to identify problems and solutions.
  • 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.
  • 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor's degree; or 8 plus years experience with a MS/MA degree.
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and produce 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.
  • Excellent planning and project management skills.
  • Good interpersonal, communication, writing and organizational skills.
  • Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC.

#GBDS

#GBDSProgramming

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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