Senior Manager- Statistical Programming

1 month ago


hyderabad, India Bristol Myers Squibb Full time

Title: - Senior Manager - Statistical Programming

Location: - Hyderabad (Hybrid)

Required relevant experience: - 9-15 years.

Strong experience required in SDTM, ADaM, TLF, Specification Creation, CDISC, P21 and Clinical submissions.


Key Responsibilities: -


Project Responsibilities: -


  • Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices.
  • Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards.
  • Leads / Supports the electronic submission preparation and review.
  • Develops unambiguous and robust programming specifications (e.g., ADaM specifications)
  • Reviews key 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.
  • Communicates proactively and effectively around issues and risks and contributes to its remediation.


Improvement Responsibilities:-


  • Identifies, leads, and supports opportunities to enhance processes and technology.
  • Communicates proactively and effectively around issues and risks and contributes to its remediation.



Managerial Responsibilities (if applicable) :-


  • Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS.
  • Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager.
  • Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
  • Communicates with manager regarding promotions, performance concerns, and retention risks.
  • Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results.




Skills, knowledge, and experience: -

Minimum Requirements: -


  • Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
  • At least 9 years programming experience in industry including support of significant regulatory filings.
  • For US positions: US military experience will be considered towards industry experience.
  • 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.


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    About the RoleBristol Myers Squibb is seeking a highly skilled Senior Manager of Statistical Programming to join our team. This is a critical role that requires expertise in statistical programming, data analysis, and project management.Key Responsibilities:Provide comprehensive programming leadership and support to clinical project teams and...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job Title: Senior Manager of Statistical ProgrammingWe are seeking a highly skilled Senior Manager of Statistical Programming to join our team at Bristol Myers Squibb. As a key member of our clinical programming team, you will be responsible for providing comprehensive programming leadership and support to clinical project teams and vendors.Key...


  • Hyderabad, India Bristol Myers Squibb Full time

    Description BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job Title: Senior Manager- Statistical Programming LeadJob Summary: We are seeking a highly skilled Senior Manager- Statistical Programming Lead to join our team at Bristol Myers Squibb. As a key member of our clinical programming team, you will be responsible for providing leadership and support to clinical project teams and vendors, ensuring compliance...


  • hyderabad, India Bristol Myers Squibb Full time

    Title: - Senior Manager - Statistical ProgrammingLocation: - Hyderabad (Hybrid)Required relevant experience: - 9-15 years.Strong experience required in SDTM, ADaM, TLF, Specification Creation, CDISC, P21 and Clinical submissions.Key Responsibilities: -Project Responsibilities: -Provides comprehensive programming leadership and support to clinical project...


  • Hyderabad, India Bristol Myers Squibb Full time

    Title: - Senior Manager - Statistical Programming Location: - Hyderabad (Hybrid) Required relevant experience: - 9-15 years. Strong experience required in SDTM, ADa M, TLF, Specification Creation, CDISC, P21 and Clinical submissions. Key Responsibilities: - Project Responsibilities: - Provides comprehensive programming leadership and support to...


  • Hyderabad, India Bristol Myers Squibb Full time

    Title: - Senior Manager - Statistical Programming Location: - Hyderabad (Hybrid) Required relevant experience: - 9-15 years. Strong experience required in SDTM, ADaM, TLF, Specification Creation, CDISC, P21 and Clinical submissions. Key Responsibilities: - Project Responsibilities: - Provides comprehensive programming leadership and support to clinical...


  • Hyderabad, India Bristol Myers Squibb Full time

    Title: - Senior Manager - Statistical ProgrammingLocation: - Hyderabad (Hybrid)Required relevant experience: - 9-15 years.Strong experience required in SDTM, ADaM, TLF, Specification Creation, CDISC, P21 and Clinical submissions.Key Responsibilities: -Project Responsibilities: -Provides comprehensive programming leadership and support to clinical project...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job Title: Senior Manager, Statistical Programming LeadAbout the Role:The Senior Manager, Statistical Programming Lead, will provide comprehensive programming expertise to clinical project teams to lead statistical programming teams and support the development, regulatory approval, and market acceptance of Bristol Myers Squibb products. This position is...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job Title: Senior Manager, Statistical ProgrammingBristol Myers Squibb is seeking a highly skilled Senior Manager, Statistical Programming to join our team. As a key member of our Global Biometrics & Data Sciences (GBDS) team, you will be responsible for providing comprehensive programming expertise to clinical project teams, leading statistical programming...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryWe are seeking a highly skilled Senior Manager, Statistical Programming Solutions to join our team at Bristol Myers Squibb. As a key member of our Global Biometrics and Data Sciences organization, you will be responsible for providing functional expertise and leadership to clinical project teams.Main ResponsibilitiesProvide comprehensive...


  • Hyderabad, India Bristol Myers Squibb Full time

    Title: - Senior Manager - Statistical ProgrammingLocation: - Hyderabad (Hybrid)Required relevant experience: - 9-15 years.Strong experience required in SDTM, ADaM, TLF, Specification Creation, CDISC, P21 and Clinical submissions.Key Responsibilities: -Project Responsibilities: -Provides comprehensive programming leadership and support to clinical project...


  • Hyderabad, India Bristol Myers Squibb Full time

    Title: - Senior Manager - Statistical ProgrammingLocation: - Hyderabad (Hybrid)Required relevant experience: - 9-15 years.Strong experience required in SDTM, ADaM, TLF, Specification Creation, CDISC, P21 and Clinical submissions.Key Responsibilities: -Project Responsibilities: -Provides comprehensive programming leadership and support to clinical project...


  • hyderabad, India Bristol Myers Squibb Full time

    Title: - Senior Manager - Statistical ProgrammingLocation: - Hyderabad (Hybrid)Required relevant experience: - 9-15 years.Strong experience required in SDTM, ADaM, TLF, Specification Creation, CDISC, P21 and Clinical submissions.Key Responsibilities: -Project Responsibilities: -Provides comprehensive programming leadership and support to clinical project...


  • Hyderabad, India Bristol Myers Squibb Full time

    Title: - Senior Manager - Statistical Programming Location: - Hyderabad (Hybrid) Required relevant experience: - 9-15 years. Strong experience required in SDTM, ADaM, TLF, Specification Creation, CDISC, P21 and Clinical submissions. Key Responsibilities: - Project Responsibilities: - Provides comprehensive programming leadership and support to clinical...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryBristol Myers Squibb is seeking a Senior Manager of Statistical Programming to provide comprehensive programming expertise to clinical project teams. This position is responsible for leading statistical programming teams and supporting the development, regulatory approval, and market acceptance of Bristol Myers Squibb products.Key...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryBristol Myers Squibb is seeking a Senior Manager, Statistical Programming to provide comprehensive programming expertise to clinical project teams. This role is responsible for leading statistical programming teams and supporting the development, regulatory approval, and market acceptance of Bristol Myers Squibb products.Key...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that improve patients' lives. We are seeking an experienced Associate Director, Statistical Programming, to join our team and contribute to the development of life-changing...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a global biopharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled Statistical Programming Manager to join our team in Hyderabad, India.Job SummaryThe Statistical Programming Manager will be responsible for providing...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job Summary: We are seeking an experienced Senior Manager, Statistical Programming and Development Lead to join our Global Biometrics & Data Sciences (GBDS) team at Bristol Myers Squibb. This role is responsible for providing comprehensive programming expertise to clinical project teams, leading statistical programming teams, and supporting the development,...