Position : Senior Statistical Programmer
Experience : 6+ Years
Job Type : Full-time
Key Responsibilities :
- Leverage advanced proficiency in SAS and R programming to support or lead complex clinical studies, ensuring data integrity and quality.
- Perform hands-on programming activities, including the creation of SDTM and ADaM datasets, as well as the generation of Tables, Listings, and Figures (TLFs) for both safety and efficacy analysis.
- Take ownership of programming tasks with minimal supervision, demonstrating a deep understanding of the study's statistical analysis plan and data structures.
- Lead all aspects of a clinical study under supervision, including coordination with data management, biostatistics, and clinical teams.
- Create and maintain comprehensive documentation, including CRF annotations, dataset specifications (SDTM, ADaM, SDRG), and a define.xml for submission.
- Identify gaps in current programming best practices and propose suggestions for improvement to enhance efficiency and compliance.
- Ensure strict adherence to applicable policies, procedures, and evolving industry standards.
- Take responsibility for the timely and accurate completion of all assigned development tasks, from initial programming to final submission.
Required Skills & Qualifications :
6+ years of hands-on experience in SAS and R programming within a clinical trial environment.Proven proficiency in CDISC standards, with practical experience in creating SDTM and ADaM datasets.Hands-on experience with the generation of TLFs for both safety and efficacy analysis.Experience with CRF annotations and the creation of dataset specifications.Demonstrated ability to lead at least one clinical study under supervision.A strong understanding of the clinical trial domain and the ability to apply this knowledge to programming activities.The ability to execute a wide range of programming activities with minimal supervision.Preferred Skills :
Experience with electronic submission processes (define.xml, P21, ADRG, SDRG).Familiarity with other programming languages, such as Python, for data analysis.Experience with SAS Grid or other high-performance computing environments.Knowledge of statistical methodologies used in clinical trials.Strong communication skills and the ability to work effectively in a team-based environment.(ref : hirist.tech)