Senior Statistical Programmer (Dombivli)
Senior Statistical Programmer (Dombivli)
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Dombivli, India -
Posted: less than a week ago
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Description
About the Company VALOS is an international, specialized CRO headquartered in Genoa, Italy, , recognized for its excellence in Biostatistics and Data Management. We partner with leading pharmaceutical and biotech companies worldwide, delivering high-quality statistical solutions that drive clinical research forward.
About the Role We are looking for talented Senior Statistical Programmer with at least 5 years of experience to join our growing Biostatistics Department in India.
Responsibilities
- Create ADAM and TFLs for clinical studies
- Apply advanced statistical methodologies to clinical trials and RWE studies
- Contribute to the development of Statistical Analysis Plans (SAPs) and study reports
- Collaborate closely with cross-functional teams (data management, Statisticians, medical writing, clinical operations)
Qualifications
- Solid understanding of clinical trials across 1-4 phases, different endpoints, analysis populations, and why TFLs are produced.
- Able to work with interventional and RWD or observational data.
- Read and interpret Protocol and SAP. Translate methods and estimands into programming requirements and traceability rules. Provide programming feedback to Statisticians and align on shells.
- Build SDTM from raw sources with end-to-end traceability to CRF and EDC exports.
- Perform precise SDTM CRF annotation aligned to CDISC SDTM IG and trial design domains.
- Apply controlled terminology and clinical dictionaries (Meddra, WHODrug, etc) in SDTM mapping
- Prepare SDRG and SDTM Define.xml. Run and resolve SDTM Pinnacle 21 findings.
- Create ADaM specifications from SAP and shells with explicit derivation rules and SDTM-to-ADaM traceability.
- Program ADaM across ADSL, BDS, OCCDS, and time-to-event. Produce ADaM Define.xml and ADRG. Close ADaM Pinnacle 21 findings.
- Understand and build TFL mock shells consistent with SAP and ADaM structure. Program and validate TFLs in SAS and R.
- Execute QC: independent review, double programming Apply on Kit Job: kitjob.in/job/4mx1qz
About the Role We are looking for talented Senior Statistical Programmer with at least 5 years of experience to join our growing Biostatistics Department in India.
Responsibilities
- Create ADAM and TFLs for clinical studies
- Apply advanced statistical methodologies to clinical trials and RWE studies
- Contribute to the development of Statistical Analysis Plans (SAPs) and study reports
- Collaborate closely with cross-functional teams (data management, Statisticians, medical writing, clinical operations)
Qualifications
- Solid understanding of clinical trials across 1-4 phases, different endpoints, analysis populations, and why TFLs are produced.
- Able to work with interventional and RWD or observational data.
- Read and interpret Protocol and SAP. Translate methods and estimands into programming requirements and traceability rules. Provide programming feedback to Statisticians and align on shells.
- Build SDTM from raw sources with end-to-end traceability to CRF and EDC exports.
- Perform precise SDTM CRF annotation aligned to CDISC SDTM IG and trial design domains.
- Apply controlled terminology and clinical dictionaries (Meddra, WHODrug, etc) in SDTM mapping
- Prepare SDRG and SDTM Define.xml. Run and resolve SDTM Pinnacle 21 findings.
- Create ADaM specifications from SAP and shells with explicit derivation rules and SDTM-to-ADaM traceability.
- Program ADaM across ADSL, BDS, OCCDS, and time-to-event. Produce ADaM Define.xml and ADRG. Close ADaM Pinnacle 21 findings.
- Understand and build TFL mock shells consistent with SAP and ADaM structure. Program and validate TFLs in SAS and R.
- Execute QC: independent review, double programming Apply on Kit Job: kitjob.in/job/4mx1qz
Highlights
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Company nameValos -
Job positionSenior Statistical Programmer (Dombivli)
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