Job Description

Responsibilities:

• Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
• Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
• Execution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
• Development and review CDISC SDTM and ADaM mapping specifications.
• Produce and review Tables, Figures, and Listings (TFLs) in accordance with the SAP.
• Review datasets for any pending compliance issues and meticulously document identified issues.
• Generation and review of submission documents like define.xml, SDTM annotated CRF, and reviewers guide.
• Generation of utility macros and efficient code writing to streamline programming processes.
• Communicate effectively within project teams to ensure the timely and budget-compliant completion of assigned tasks.
• Adherence to Clymb and/or client’s Policies and Procedures.

Requirements:

• Master’s degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 5 years of SAS programming experience. Alternatively, a Bachelor’s degree with 7+ years of SAS programming experience.
• A minimum of 3 years of hands-on CDISC implementation experience. Any experience with R programming will be considered a significant plus.
• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
• Previous involvement as a production or QC programmer at both product and study levels.
• Strong organizational, interpersonal, leadership, and communication skills.
• Ability to autonomously manage multiple tasks and projects.
• In-depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.
• A minimum requirement of a strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.

Skills: