Description
Key Features-Serve as lead programmer and use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways for one or more clinical studies.
-Review and help develop documents related to study (Case Report Forms, Database Specifications, Statistical Analysis Plans, TLF specifications, etc).
-Define analysis dataset specification and ensure that specifications are met.
-Development of data definition tables based on analysis dataset specifications and company standards and policies.
-Implement QA and QC validation in accordance with departmental SOP's for deliverables including:
-Analyze and evaluate clinical data for completeness, correctness and consistency
-Collaborate with statisticians and support programmer(s) on programming tasks and validation.
-Participate in technical development and process improvement within Statistical Computing.
-Develop, apply and promote consistent programming standards through standard processes and SOPs.
-Work collaboratively with interdepartmental stakeholders (e.g., Clinical Operations, Drug Safety, Regulatory, Analytical Chemistry and Medical Affairs) to clarify program objectives, resolve issues, and gain efficiencies
Requirements:
-Experience is within the pharmaceutical/biotech industry or relevant clinical research organization Industry
-Experience in the development of analysis files and quality assurance of data
-Experience in programming within a regulated environment
-Experiences with Clinical Study Reports, NDA submissions and Oncology preferred
-BS/BA/MS in Statistics, Computer Sciences, Mathematics, or Life Sciences.
To find out more about Real please visit www.realstaffing.com