ProcDNA - Senior Statistical Programmer - R/SAS

4 weeks ago

Gurugram, India PROCDNA ANALYTICS PRIVATE LIMITED Full time

Position : Senior Statistical ProgrammerExperience : 6+ YearsJob Type : Full-timeKey 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)

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