Clinical R&D SAS Programmer – Statistical Modeling

Position : Clinical R&D SAS Programmer

Location : Jaipur, Rajasthan

Budget : 18 LPA

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