Manager of Data Standards and Programming

Pharmacuetical company hiring for a Manager of Data Standards and Programming

Responsible for implementation, maintenance and update of Otsuka global SDTM specifications and controlled terminologies. Develop and maintain standard programing library and templates for SDTM transformation. Work collaboratively with Data Management personnel to map and convert raw data collected on CRF and through other sources into SDTM for clinical studies. Generate and review SDTM annotated CRF, define.xml and Study Data Reviewer's Guide (SDRG) for clinical studies to support regulatory submissions. Validate SDTM datasets for compliance with Pinnacle 21 and other relevant requirements. Review and archive SDTM data related documents generated internally and external service providers. Support SDTM loading into warehouse and up-versioning of SDTM as required.
Implement, maintain and update global SDTM specification and controlled terminologies.
Work collectively with Data Management personnel to review global CDASH specifications and EDC/eSource global libraries.
Work collaboratively with Data Management Lead to define study-specific SDTM domains, variables and codelists.
Manage MDR (metadata repository) and associated DSP (data standardization platform) system to upgrade, develop workaround solutions, and provide training as needed.
Develop programming standards, templates and library to ensure consistency, improve quality and reduce SDTM programming timeline for clinical studies.
Develop custom validation check, in addition to Pinnacle 21, to ensure conformance and quality of the raw and SDTM data.
Assist in developing Working Procedures, Best Practices and training materials to support SDTM transformation.
Perform SDTM transformation to support clinical studies in accordance with SOPs, guidance documents, and utilizing a data conversion tool.
Perform SDTM annotations on blank Case Report forms for clinical studies to support regulatory submissions.
Generate define.xml for SDTM data as required for regulatory submission.
Review and update Study Data Reviewer's Guide to document any standard conformance related issues.
Perform quality control of CDISC SDTM domain output in accordance with SOPs, guidance documents and utilizing validation tools, including Pinnacle 21.
Review and validate SDTM transfer from CRO and other Otsuka affiliates and partners.
Provide support to the loading of SDTM data into Otsuka Global Data Warehouse.
Archive SDTM related documents to ensure inspection-ready by regulatory agencies.
Support submission-related deliverables including SDTM datasets, annotated CRF, Study Data Reviewer's Guide.
Coordinate with Clinical Programming, Biostatistician and Data Management personnel to resolve any data format related issues.
Provide training to internal and CRO personnel on MDR system and SDTM as necessary.

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

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