QC Programmer (SDTM/ADaM)

As a QC Programmer (SDTM/ADaM) reporting to the Operation Head in India, your role involves performing independent validation and quality control of SDTM and ADaM datasets, as well as Tables, Listings, and Figures (TLFs) for clinical studies. You will validate programming outputs, review derivations, and support FDA/EMA submissions in accordance with CDISC standards and industry best practices. Located in Hyderabad, Telangana, India, your responsibilities include: - Perform independent validation of SDTM and ADaM datasets - Conduct double programming and independent QC checks for clinical study deliverables - Review SAS logs, outputs, and programming documentation for accuracy and completeness - Validate derivations against approved specifications, SAPs, and study requirements - Support FDA/EMA submission readiness activities - Create, validate, and QC Tables, Listings, and Figures (TLFs) using SAS - Develop and QC ADaM datasets as per CDISC standards - Validate SDTM mappings and dataset structures - Ensure compliance with CDISC SDTM and ADaM implementation guidelines - Participate in submission package preparation and review activities - Review and validate define.xml and associated metadata documentation - Collaborate with Biostatistics, Data Management, and Clinical teams to resolve discrepancies and ensure quality deliverables Qualifications and Experience: - Bachelors or Masters degree in Statistics, Computer Science, Life Sciences, Pharmacy, or related field - Experience working on regulatory submissions for FDA/EMA - Knowledge of Pinnacle 21 validation checks - Strong analytical and problem-solving skills - Good communication and collaboration abilities - 4 - 8 years of experience in Clinical SAS Programming / QC Programming - Hands-on experience with SDTM, ADaM, and TLF validation in clinical studies Skills & Competencies: - Strong SAS programming skills in clinical domain - Good understanding of CDISC standards including SDTM and ADaM - Experience in TLF generation and validation - Familiarity with define.xml and metadata review - Knowledge of clinical trial processes and regulatory requirements - Understanding of Protocol, SAP, and CRF - Experience in QC and validation methodologies This position operates in an office setting, in person. Job may additionally require you to be available outside of these hours to handle priority business needs. As a QC Programmer (SDTM/ADaM) reporting to the Operation Head in India, your role involves performing independent validation and quality control of SDTM and ADaM datasets, as well as Tables, Listings, and Figures (TLFs) for clinical studies. You will validate programming outputs, review derivations, and support FDA/EMA submissions in accordance with CDISC standards and industry best practices. Located in Hyderabad, Telangana, India, your responsibilities include: - Perform independent validation of SDTM and ADaM datasets - Conduct double programming and independent QC checks for clinical study deliverables - Review SAS logs, outputs, and programming documentation for accuracy and completeness - Validate derivations against approved specifications, SAPs, and study requirements - Support FDA/EMA submission readiness activities - Create, validate, and QC Tables, Listings, and Figures (TLFs) using SAS - Develop and QC ADaM datasets as per CDISC standards - Validate SDTM mappings and dataset structures - Ensure compliance with CDISC SDTM and ADaM implementation guidelines - Participate in submission package preparation and review activities - Review and validate define.xml and associated metadata documentation - Collaborate with Biostatistics, Data Management, and Clinical teams to resolve discrepancies and ensure quality deliverables Qualifications and Experience: - Bachelors or Masters degree in Statistics, Computer Science, Life Sciences, Pharmacy, or related field - Experience working on regulatory submissions for FDA/EMA - Knowledge of Pinnacle 21 validation checks - Strong analytical and problem-solving skills - Good communication and collaboration abilities - 4 - 8 years of experience in Clinical SAS Programming / QC Programming - Hands-on experience with SDTM, ADaM, and TLF validation in clinical studies Skills & Competencies: - Strong SAS programming skills in clinical domain - Good understanding of CDISC standards including SDTM and ADaM - Experience in TLF generation and validation - Familiarity with define.xml and metadata review - Knowledge of clinical trial processes and regulatory requirements - Understanding of Protocol, SAP, and CRF - Experience in QC and validation methodologies This position operates in an office setting, in person. Job may additionally require you to be available outside of these hours to handle priority business needs.