Clinical Programmer

1 day ago

Redwood City, United States Planet Pharma Full time

This position is a Clinical SAS Programmer opportunity. We are unable to provide sponsorship for this opportunity, and unable to work with 3rd party candidates. Candidates must have some experience working in a Pharmaceutical, Biotechnology, or CRO supporting the Clinical Data Management team for Phase I-III Clinical trial data. Candidates must have SAS programming skills and some experience working with EDC systems (Rave, Veeva, Medrio etc.). Candidates who have worked exclusively in Hospital, Healthcare, Academia or Pharmacy environments will not be considered for this role.


The Opportunity:

The Clinical Data Analyst is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review through database lock of clinical trials. The Clinical Data Analyst has a fundamental knowledge of the data management process and can help plan, manage and coordinate all Data Management activities for assigned study(ies) with some guidance. This person may work closely with junior data managers and/or Clinical Data Associates (CDAs). The core duties and responsibilities of the CDA are delineated below. Specifically, you will be responsible for:

  • Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review the data transfer specifications, and transfer data from external sources, ensuring data is received and validated for data integrity.
  • Collaborate in the development of programming specifications and the creation of program-specific validation plans using established validation practices and processes.
  • Provide technical SAS programming expertise to support data management, including the development, validation, implementation, and maintenance of data review listings, metrics, dashboards, and reconciliation reports for all studies.
  • Work experience in using CRF-Annotation, FDA regulations such as CDISC, 21 CFR Part 11, ICH, GCP guidelines, and other regulatory submissions to the NDA.
  • Participate in the development and implementation of SAS programming standards, SOPs, and work instructions, including program validation and documentation.
  • Work with data managers and generate outputs to support data cleaning, enhance data integrity, and ensure timely, targeted, and accurate deliverables.
  • Ensure quality and timely delivery of clinical trial data in preparation for data review and statistical review.
  • Address data issues identified by cross-functional team members.
  • Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities).
  • Contribute to the development of SAS macro programs and participate in modifying existing SAS macro programs to improve efficiency throughout the project life cycle.

Required Experience, Skills, and Education:

  • MS, BS/BA degree or other suitable qualification with relevance to the field.
  • Custom reporting using Business Objects, SAS, Python, Crystal Reports, and understanding of Medidata Rave Study Build.
  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.
  • Should have real-time 2+ years of work experience in Phases I, II, and III oncology clinical trial studies.
  • Quick learner, self-starter, effective troubleshooter, and good at resolving data issues, committed to continuous learning and improvement, and should be a team player.
  • Effective written and oral communication skills required.

Preferred Skills:

  • Possessing SAS certification, work experience in Spotfire or Tableau or Power BI and windows batch script is preferred.

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