Serve as a leading role in statistical programming: provided high-level statistical programming support to a wide range of clinical trials as a consultant, both internal and external; make a significant contribution to the statistical programming standardization. The individual also serves as a pivotal role for process and project management.
Job Responsibilities:
- Robust oral and written communication skills
- Experience in handling complex efficacy domains and TFLs
- Act as subject matter expert for large-scale complex projects, providing hands-on support for the completion of projects. Solve critical technical problems.
- Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM/ADAM specifications, datasets, and TLFs.
- Ensures excellence and high quality in the programming of analysis-ready datasets, tables, listings,
and figures for which they are responsible.
- Provide support to mentor and train junior team members.
- Ensure all statistical activities are in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements.
- Proficiency in SAS and CDISC for programming, as well as programming management skills for the project leader role.
- Experience in specialized therapeutic areas (TAs) such as oncology, immunology, and neurology would be a plus.
Core Strength:
- The candidate should be technically sound and have hands-on experience in Statistical Programming.
- Responsible for appropriate code reviews and ensuring quality checks are performed on deliverables.
- Issues would be raised about timelines, deliverables, and quality directly, and he/she would be the key communicator in resolving problems at a team level.
- Providing support for onboarding additional program
📌 Statistical Programmer (Bengaluru)
🏢 The Whiteboard
📍 Bengaluru
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