Statistical Programming Manager
1 month ago
Bristol 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.
Key Responsibilities- Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures.
- Perform programming validation to ensure quality of analysis datasets and programming outputs.
- Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis.
- Support the electronic submission preparation and review.
- Review key planning documents to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.
- Assess the impact on programming activities.
- Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers.
- Provide leadership for ensuring 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.
- Identify opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors.
- Support improvement initiatives.
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences.
- At least 3 years of programming experience in industry.
- 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.
- Minimum of 3 years of clinical/statistical programming experience within pharmaceutical clinical development.
- 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 is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees.
We are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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