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Clinical Programmer - Pharma
Ref No.: 20-00393
Location: Summit, New Jersey
Job Description:
  • Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF) for studies.
  • Serve as Study SDTM Programming lead for all regulatory submissions.
  • Expertise in SDTM automation tools, macros and using them for SDTM programming.
  • Strong understanding of 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 guidelines and appropriate metadata to reflect tabulation datasets.
  • Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 andQuality 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.
  • Provide programming input to CRF and External Data from an SDTM perspective.
  • Oversee development of SAS programs to generate SDTM datasets.
  • Validation of SDTM datasets to ensure meets regulatory compliance.
  • Provide input to the design of the clinical trial database from an SDTM perspective.
  • Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
  • Ensure that all programming deliverables are compliant with CDISC.
  • Partner with CROs and act as a primary point of contact for SDTM programming activities.
  • Provide SDTM programming input into the SOW activities and review associated budget.
  • Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables.
  • Receive, process and review datasets, as well as data review reports from CROs.
  • Ensure that programming best practices are adhered to by both CRO and programmers.
  • Participate in study/project team meetings as a core member and provide technical expertise/support.
  • 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.

  • BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 7 plus years of experience supporting clinical trials for regulatory submissions CDISC.
  • Experience as a Lead Programmer overseeing the SDTM activities of support programmers as well as CRO/external vendors.
  • Strong project management skills; good communication skills; ability to work in a cross-functional team environment.
  • Experience with CDSIC standards including CDASH or SDTM/ADaM.
  • Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
  • Knowledge of clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation.
  • Demonstrates expertise in the handling and processing of upstream data including multiple data sources, data workflow, eDC, SDTM.
  • Demonstrates expertise in providing outputs to meet downstream requirements including ADaM, Data Definition Table, e-submission.
  • Proficient in programming languages and demonstrated proficiency in using SAS to produce SDTM datasets.
  • In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practices.
  • In depth understanding of regulatory, industry, and technology standards and requirements.
  • In depth understanding of statistical terminology, clinical tests, medical terminology, and protocol designs.
  • Demonstrate ability to work in a team environment with clinical team members.
  • Excellent communication skills, excellent written, verbal, interpersonal and organizational skills.
  • Excellent planning and project management skills as well as vendor management.