Manager, Statistical Programming
Summary:
Managers of Statistical Programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Statistical programmers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.
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
- Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
- Support the electronic submission preparation and review
- Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements. Assess impact on programming activities.
- Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
- Provides 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
- Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
- Independently leads and / or performs programming assignments across multiple projects with minimal supervision
- Support improvement initiatives
Minimum Requirements:
- Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
- At least 4 years programming experience in industry.
- For US positions: US military experience will be considered towards industry experience.
- Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
- Have in-depth 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.
- Have good understanding of regulatory, industry, and technology standards and requirements.
- Have 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:
- Minimum of 4 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