Statistical Programming Lead

5 days ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time
Job Description

Bristol Myers Squibb is seeking a highly skilled Associate Director, Statistical Programming to join our team. This role is responsible for providing functional expertise and leadership to clinical project teams, driving the development and implementation of innovative strategies and technologies for clinical trial programming.

Key Responsibilities
  • Provides comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices.
  • Drives the development and implementation of innovative strategies and technologies for clinical trial programming.
  • Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards.
  • Leads the electronic submission preparation and review.
  • Develops unambiguous and robust programming specifications (e.g., ADaM specifications).
  • Reviews planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; assesses document robustness and impact on programming activities.
Requirements
  • Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required.
  • At least 10 years programming experience in industry, including support of significant regulatory filings, and minimum 5 years of experience in managing technical professionals in a regulated environment.
  • Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
  • Broad expertise in statistical programming and in developing computing strategies.
  • In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases.
  • Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g., MS Office, XML, Pinnacle 21).
  • Demonstrated ability in processing of upstream data (e.g., multiple data forms, workflows, eDC, SDTM); demonstrated ability in providing deliverables to meet downstream requirements (e.g., ADaM, TFLs, e-submission components).
  • Demonstrated ability to work in a team environment with clinical team members.

Bristol Myers Squibb is an Equal Employment Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Bristol Myers Squibb is committed to diversity and inclusion.

Join our team and contribute to the development of innovative treatments that transform patients' lives.

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