Sr Mgr Statistical Programming
Bangalore, India, 560064
Who we are
The opportunity
- The Senior Manager, Statistical Programming, provides comprehensive programming leadership for programming deliverables within a product/program. This role is responsible for managing the timely and accurate execution of programming components of clinical trials and supports the development, regulatory approval and market acceptance of Teva Products.
- The Senior Manager leads and manages projects that involve global tasks, cross functional teams, or outsourcing resources. The role requires providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, the Senior Manager of statistical programming supports improvement initiatives, support change management through communication, training, and stakeholder engagement, and proactively address risks with remediation strategies.
How you’ll spend your day
- Primarily works at the product / program level
- Possible to have direct reports; Likely to oversee contingent workers and/or vendors; likely to provide training to others; Analyzes needs to manage resources. Mentor Jr Level programmers on the use of department standardization tools/processes.
- Manages and Delivers assignments with quality and within timelines and provides input for budget planning
- Independently develops, validates, and maintains complex programs and utilities in accordance with predefined specifications and standards.
- Provides strong programming support to CDISC based e-submission. Develop, review, and/or perform validation of generic macros. Develop, debug, and enhance SAS (or any other Statistical software) programs to support quality control of safety or efficacy derived datasets.
- Reviews key planning documents (e.g, Protocol, statistical analysis plan) to ensure alignment with project objectives, contributes to development of data presentation plan (DPP) , programming specifications (eg. SDTM, ADaM specs) , regulatory reviewers guide documents, ensures clarity and completeness of programming requirements, and robustness of assumptions.
- Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource issues.
- Responsible for the standardization of GSD deliverables across study projects within an indication/therapeutic area.
- Contributes to the overall definition of programming rules and standardization across therapeutic areas and/or indication, including supporting visualization capabilities.
- Identifies, supports process and technology improvement initiatives, communicates proactively and effectively around issues and risks and contributes to remediation strategies.
- Leads global projects with cross-functional involvement; demonstrates project management and leadership capabilities.
- Contributes to departmental policies, standards, and best practices.
Your experience and qualifications
- Bachelor’s Degree/Master’s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
- Bachelors + 12 year, Masters + 10 years in a pharmaceutical or clinical research setting as a programmer.
- Expert level of programming skills and problem resolution in SAS or other Statistical programming software. Provide programming and documentation support for SAS (or other Statistical software) system development
Reports To
- Director Statistical Programming
Teva’s Equal Employment Opportunity Commitment