Join to apply for the SAS Programmer III role at Katalyst CRO
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Join to apply for the SAS Programmer III role at Katalyst CRO
- Review and ensure accurate and high-quality statistical programming deliverables from CRO.
- Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance with SOPs, SOIs, and guidance documents.
- Create and maintain specifications as per SDTM/ADaM standard and study SAP.
- Define and create ad-hoc reports and listings for clinical teams.
- Develop, implement and maintain SAS programming standards.
- Builds/tests programs for Data Validation, Derivation, and Data Reports to identify inconsistencies and support data review efforts, as necessary.
- Verifies completeness of relevant study deliverables prior to release from the group
- Maintains all required study documentation.
- Consults and provides input into system validation efforts including tool maintenance activities.
- Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.
- Work in tandem with Biostatistics and Data Management member on various clinical projects.
- Review CRF annotations and data specifications.
- Perform quality control on final reports.
- Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
- Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
- Perform clinical study report and/or exploratory analysis for oncology clinical study.
- Perform validation of ADaM datasets and TLFs per SAP.
- Effectively review and comment on vendor programming deliverables and help resolve technical difficulties.
Responsibilities
- Review and ensure accurate and high-quality statistical programming deliverables from CRO.
- Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance with SOPs, SOIs, and guidance documents.
- Create and maintain specifications as per SDTM/ADaM standard and study SAP.
- Define and create ad-hoc reports and listings for clinical teams.
- Develop, implement and maintain SAS programming standards.
- Builds/tests programs for Data Validation, Derivation, and Data Reports to identify inconsistencies and support data review efforts, as necessary.
- Verifies completeness of relevant study deliverables prior to release from the group
- Maintains all required study documentation.
- Consults and provides input into system validation efforts including tool maintenance activities.
- Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.
- Work in tandem with Biostatistics and Data Management member on various clinical projects.
- Review CRF annotations and data specifications.
- Perform quality control on final reports.
- Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
- Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
- Perform clinical study report and/or exploratory analysis for oncology clinical study.
- Perform validation of ADaM datasets and TLFs per SAP.
- Effectively review and comment on vendor programming deliverables and help resolve technical difficulties.
Requirements:
- BS or above in computer science/statistics with at least 5 years of SAS experience in major pharma or CRO.
- Develop SAS coding for generating SDTM, ADaM datasets and TLFs to support clinical study analysis.
- Proficient computer skills across multiple applications and OS environments.
Seniority level
- Seniority levelNot Applicable
Employment type
Job function
- Job functionInformation Technology
- IndustriesPharmaceutical Manufacturing
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