Lead Clinical Data Analyst

Senior Clinical Statistical Programmer Job

This role involves the development, mapping and validation of SDTM datasets as per CDISC standards and regulatory requirements.

• Develop SDTM datasets according to CDISC standards and regulatory requirements.
• Perform Pinnacle 21 validation and resolve compliance issues for FDA / PMDA submissions.
• Standardize and transform Real-World Data (RWD) into CDISC-compliant formats.
• Work with biomarker data to ensure alignment with clinical datasets for integrated analysis and interpretation.
• Develop CDISC submission packages including Define.xml, cSDRG, and ADRG documentation to ensure compliance with regulatory standards.
• Participate in review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM / ADAM specifications, datasets, and TLFs.
• Ensure high-quality programming of analysis-ready datasets, tables, listings, and figures.
• Support mentorship and training of junior team members.
• Maintain statistical activities in accordance with internal and external quality standards, SOPs / WPDs, ICH-GCP, and / or other international / local regulatory requirements.

Key Requirements :