Lead Clinical Statistical Programmer

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 :