Senior Clinical Statistical Programmer

3 weeks ago

Nellore, India Whatjobs IN C2 Full time

Location: Bangalore/ Mumbai /Remote (WFH) Experience: 6.5+ years Job Responsibilities: Strong oral and written communication skills Develop, map, and validate SDTM datasets (Study Data Tabulation Model) as per CDISC standards and regulatory requirements. Perform Pinnacle 21 (P21) validation and resolve compliance issues for FDA/PMDA submissions. Work with Real-World Data (RWD) to standardize and transform data into CDISC-compliant formats. Worked with biomarker data, ensuring alignment with clinical datasets to support integrated analysis and interpretation. Experienced in developing CDISC submission packages, including Define.Xml, cSDRG, and ADRG documentation, ensuring compliance with regulatory standards. Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM/ADAM specifications, datasets, and TLFs. Ensures excellence and high quality in the programming of analysis-ready datasets, tables, listings, and figures for which they are responsible. Provide support to mentor and train junior team members. Ensure all statistical activities are in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements. Proficiency in SAS and CDISC for programming, as well as programming management skills for the project leader role. Core Strength: The candidate should be technically sound and have hands-on experience in Statistical Programming. Responsible for appropriate code reviews and ensuring quality checks are performed on deliverables. Issues would be raised about timelines, deliverables, and quality directly, and he/she would be the key communicator in resolving problems at a team level. Providing support for onboarding additional programmers and mentoring them. *Relevant industry experience is mandatory. Freshers may kindly refrain from applying.

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