Provides medical expertise for site identification, study feasibility, study design, conduct, analysis
and reporting, generation of integrated databases, pooled analyses for efficacy and safety, ISE and ISSs,
dossiers for regulatory submissions for market authorizations of new medicinal products, and diagnostics
and devices.
Job Responsibilities
- Generate/Produce/Create
- Table, figures, listings and datasets to support the analysis of clinical trials data
- TFL shells, primary and derived secondary datasets
- Ad hoc programmes to provide information to the project team and/or client as required
- Review
- Data edit specifications, data handling guidelines, case report forms
- Programs and command files
- Reports for consistency between text and tables
- Perform
- Billable work in accordance with PRA's policies, procedures and standard operating
procedures(SOPs)
- Ongoing self instruction of new computer system features
- New SAS procedures and techniques
- Work with Biostatisticians/ Pharmacokineticists/Medical writers/other operations staff
- To generate data summaries
- Identify inconsistencies or problems in the database and report findings
- To provide technical oversight and leadership in the areas of analysis and reporting
- To mentor new analysis programmers
- To serve as a resource for and interact to facilitate project timelines
- Maintain familiarity with the protocol, annotated CRFs and statistical analysis plans of
assigned projects
- Act as a representative and provide inputs for analysis and reporting initiatives
- Mentor new analysis programmers
- Assist with bid proposals and marketing presentations
Qualifications/Experience
- Bachelor's/Master's degree in a computer science, statistics, clinical research, biotechnology,
from an appropriately accredited institution.
- Minimum of 3 years of SAS Programming experience with particular emphasis in MACRO language.
- Work history at a Clinical Research Organization (CRO) or CRO management experience in SAS
Programming is required.
- Knowledge of data structure standards (e.g. CDISC) preferred