Site Name: Bengaluru Luxor North Tower
Posted Date: Sep 7 2021
The Senior Programmer acts as a support for GSK clinical trials, accountable for creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and GSK / industry standards.
- Plan and manage programming activities across multiple studies to deliver all data analysis outputs to agreed timelines and quality, (e.g., analysis datasets, tables, figures and listings for regulatory submissions and publications).
- Oversee outsourced tasks to third party vendors to meet the agreed timelines, quality and budget requirements established for the project or study.
- Implement data standards within a function, or therapeutic area in accordance with industry standards
- Responsible for programming and QC across a study/asset including submission activities adhering to relevant SOPs / policies.
- Participate in the design of other study delivery components (e.g. case report forms, study databases).
- Review and input into key study documents (e.g. SAP, CRF etc).
- Develop broader technical knowledge and expertise (e.g. UNIX scripting, computing environments).
- Provide technical advice, mentoring and training as relevant.
- Identify recurring problems and work with colleagues to initiate process improvement
- Bachelors Degree in Engineering, Biotechnology, Computer Applications or related disciplines
- More than 2 years experience in SAS programming (including SQL and SAS macro language)
- Proficient in SAS programming and SAS macro code development.
- Effective written and verbal communication skills.
- Knowledge of other SAS modules (e.g. SAS/GRAPH, SAS Output Delivery System).
- Knowledge of non-SAS programming packages/languages (e.g. Spotfire, S-Plus, R)
- A good level of understanding of the pharmaceutical regulatory and reporting processes (e.g. 21 CFR Part 11).
- Working knowledge of CDISC data standards, primarily the creation and use of ADaM datasets
- Experience of interacting with clinical study team members
- Ability to learn and apply advanced programming skills independently
- Ability to manage conflicting demands and priorities
- Experience of the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g., working with/for CROs, academic institutions)
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