Sas Programmer with clinical

Experience; 2+

Duration; 6Months

Roles and Responsibilities: Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF) for Client studies Serve as Study SDTM Programming lead for all regulatory submissions Expertise in Client SDTM automation tools, macros and using them for SDTM programming Strong understanding of Client EDC, SDTM metadata and metadata driven Review the Study EDC specification and ensure all collected study data (including external) is mapped appropriately in target SDTM model Design the SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements Annotate CRFs and Review annotated CRFs in accordance with Client guidelines and appropriate metadata to reflect tabulation datasets Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and Client Quality tools Collaborate with stakeholders and Study team members to manage study timelines, and resolve issues Represent SDTM Programming function in Study team meetings as well as cross-functional working groups and process improvement activities Provide subject matter expertise in defining the mapping relationships between source EDC and target SDTM domains Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies Remain abreast with latest industry trends in standards implementation, review published papers and participate in industry conferences Direct responsibility preparing and presenting SDTM information cross functionally Resolve problems as they arise within defined procedures and escalate if necessary at appropriate time Represent as internal team leader who decides best course of action Negotiate, assess, and monitor project priorities/timelines for SDTM components Review synopsis and/or protocol and provide comments for the Review Committee.

Job Skills: Build networks to achieve influence with other functions and represent as SDTM Programming technical expert. Lead/participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents Ensure consistency and adherence to standards and governance within their therapeutic area and the department Routine interface with cross-functional team members during the study startup and execution. Lead/Participate in programming team meetings when appropriate Represent programming during internal audits as well as Health Authority audits Align with the department and company strategy and model.