Senior Statistical Programmer /Analyst Consultant (3 days Hybrid at Malvern PA)

Job Summary

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.

Responsibilities

• 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.

Qualifications & Experience

• 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.