ProcDNA - Senior Statistical Programmer - R/SAS

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.