About The Position

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. The contract Senior Statistical Programmer is a member of the Biometrics Department within the Research and Development (R&D) organization who supports Statistical programming work in accordance with corporate standard operating procedures (SOPs), GCP, 21 CFR and ICH guidance.

Requirements

  • Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline.
  • BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry.
  • Working knowledge of SAS and its various components.
  • Knowledge of R programming in clinical trials
  • Familiarity of the drug development process.
  • Strong SAS and SAS Macro language skills.
  • R programming skils in clinical trials
  • Strong knowledge of industry standards.
  • Ability to work on data integrations (ISS and ISE).
  • Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience.

Responsibilities

  • Programing for clinical trials: Program and validate derived datasets, tables, figures, listings. Process data from the external sources.
  • Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations.
  • Oversee programing work/deliverables from CROs.
  • Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages.
  • Electronic submissions: Program and validate CDISC compliant deliveries for the electronic submissions.
  • Support in the creation of supporting documentation for submissions.
  • Project Management: Ensure programming deliverables are on time and of high quality.
  • Help managing internal contractors and external vendors.
  • Standards and Guidelines: Participate in development of departmental working instructions and guidelines.
  • Help in creation of enhanced functions/macros and utilities.
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