Clinical R&D SAS Programmer

This position is for a Clinical R&D SAS Programmer in Jaipur, Rajasthan, requiring 8+ years of experience. The role involves assisting in the review of study documents, writing and validating SAS programs for analysis datasets, TLGs, and presentation output, and creating CDISC standard SDTM and ADaM datasets. Candidates must have strong experience in Oncology Imaging Endpoints and FDA Approvals Submissions, along with proficiency in various SAS components and statistical methodologies.

Must Have

• Oncology Imaging Endpoints
• FDA Approvals Submissions
• Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output
• Write CDISC standard dataset specifications and create SDTM and ADaM datasets
• Understand and execute department-, product- and study-level macros and utilities
• Strong SAS Programming skills
• Extensive hands-on experience in CDISC standards and datasets (SDTM, ADaM)
• Experience in FDA/EMEA trial submissions

Good to Have

• Bachelors or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences or another relevant scientific subject
• Experience in Drug Development (pre-, early, late and/or observational) in related industries or academic research

Must Have

• Oncology Imaging Endpoints
• FDA Approvals Submissions (mandatory requirement)

Responsibilities

• Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents
• Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
• Write CDSIC standard dataset specifications and follow specifications to create SDTM and ADaM datasets
• Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities.
• Strong experience in Oncology endpoints

Knowledge

• Computer programming using SAS including SAS Macro, SAS STAT, SAS GTL, SAS Base and other relevant components of SAS as applicable.
• Understanding of computer operating systems, word processors, document applications
• Statistical Methodologies and Statistical SAS Procedures
• Strong experience in Oncology endpoints

Preferred Qualifications

• Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or another relevant scientific subject
• 8+ years clinical research and development statistical programming experience using SAS
• Strong SAS Programming skills
• Extensive hands-on experience in CDSIC standards and datasets (SDTM, ADaM)
• Strong experience in Oncology endpoints
• Experience in FDA/EMEA trial submissions
• Drug Development (pre-, early, late and/or observational) in related industries or academic research

Job Features

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| Job Category | Permanent |