Statistical Programming Manager

2 days ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

Transforming Patients' Lives through Science


Bristol Myers Squibb is a global biopharmaceutical leader that is committed to transforming patients' lives through science. We are seeking a highly skilled Manager of Statistical Programming to join our team in Hyderabad.


As a Manager of Statistical Programming, you will be responsible for providing programming expertise to clinical project teams to support the development, regulatory approval, and market acceptance of Bristol Myers Squibb products. You will design, develop, and implement technical solutions for analyzing and reporting clinical data.


You will work collaboratively with cross-functional teams to ensure the quality and integrity of clinical data. Your expertise in programming languages such as SAS, R, or other programming languages will be essential in producing derived analysis datasets and TFLs.


Key responsibilities include:



  • Creating SAS programs to generate derived analysis datasets and content for tables, listings, and figures
  • Performing programming validation to ensure the quality of analysis datasets and programming outputs
  • Providing programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis
  • Supporting electronic submission preparation and review
  • Reviewing key planning documents to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements
  • Assessing the impact on programming activities
  • Interacting with vendors regarding project standards, programming conventions, programming specifications, and file transfers
  • Providing leadership for ensuring the quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices
  • Identifying opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
  • Supporting improvement initiatives

Requirements include:



  • Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required
  • At least 3 years programming experience in industry recommended
  • For US positions: US military experience will be considered towards industry experience
  • Demonstrated proficiency in using SAS, R, or other programming languages to produce derived analysis datasets and TFLs
  • Understanding of clinical data structure (e.g. CDISC standards) and relational database
  • Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21
  • Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM
  • Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission
  • Good 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
  • Preferred requirements include: minimum of 3 years clinical/statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA)
  • Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements
  • Experience in other software packages (e.g. R)
  • Experience with the Linux operating system

Bristol Myers Squibb offers a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.


BMS has a diverse and inclusive culture that promotes diversity in clinical trials. We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles.


BMS strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.


BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.


Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.


Join BMS and be part of a team that is transforming patients' lives through science.

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