Hello, we are hiring now.
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.
Remote, 12-month initial contract with potential to renew
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.