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Search for Jobs by Ali Henderson

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Remote Clinical Data Programmer (Science & Biotech)
Remote, CA 91012
Recruited by: Ali Henderson | Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: Simulstat's client
  • Industry: Science & Biotech
  • Compensation: Depends On Experience
  • Expires: Feb 14, 2023
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Job Description

Remote, 12-month initial contract with potential to renew



The Contract Senior Clinical Programmer will be responsible for the planning, implementation, and compliance of clinical trial data programming activities across multiple studies to produce high quality and timely deliverables for Data Management, and other internal stakeholders. The role will mainly focus on clinical data ingestion and transformation, including the generation of validation procedures/data quality edit checks, reports, listings, trackers, metrics, and dashboards. The position reports to the Director, Clinical Programming.



Responsibilities include:



Produce timely, high quality, and reliable clinical trial data listings, reports, and trackers for data cleaning, data review, adjudication, and study status tracking
Provide input to the clinical data reporting requirement, data validation and data transfer specifications (if applicable) to ensure high quality deliverables
Perform ingestion activities of multiple external data (Safety, ePRO, IRT, PK, etc.)
Perform external data reconciliation and data quality check programming activities
Perform ad hoc flexible and rapid programming arising from Data Management needs
Collaborate with internal stakeholders and cross functional team members within Biometrics, Clinical Operations, and Clinical Development
Contribute to the development and maintenance of a positive team-focused company culture


Education, Experience, and Skills:



Bachelor’s degree or higher in a technical, scientific, or analytic discipline
Minimum of 5 years experience supporting clinical and/or statistical programming activities in clinical research for all phases of clinical trials
Solid knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, ICH, 21 CFR part 11, and other related guidance documents
Excellent SAS programming skills, with a thorough understanding of clinical data structures, Proc SQL, SAS macro and general database concepts
Experience with EDC applications, preferably Rave EDC or Veeva CDMS
Knowledge of advanced SQL concepts, JSON and Veeva CDB (a plus)
Experience with varied business intelligence and analytic tools, Looker, R Shiny, Spotfire, Power BI, Tableau, and/or SAP BusinessObjects
Knowledge of and experience with CDISC standards including CDASH and SDTM.
Ability to critically analyze information, communicate outcomes, and prioritize actions
Excellent computer skills; strong verbal and written communication skills
Ability to work well in a cross-functional teams as a contributor
Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships