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.
- Program and validate CDISC compliant deliveries for the electronic submissions.
- Support in the creation of supporting documentation for submissions.
- Ensure programming deliverables are on time and of high quality.
- Help managing internal contractors and external vendors.
- Participate in development of departmental working instructions and guidelines.
- Help in creation of enhanced functions/macros and utilities.
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.
Work Arrangement
Hybrid
Additional Information
- 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.
- The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
