– 12 month onsite contract Connecticut
- Develop and maintain SAS datasets as per the CDISC (SDTM and ADaM) standards;
- Extract data from various databases;
- Develop and maintain SAS and R programs to analyze the data and produce reports consisting of Tables, Listings and Graphs that are generated from various databases;
- Apply Programming Development Life Cycle (PDLC) principles;
- Develop programs using SAS(Statistical Analysis Software) and R;
- Perform Programming using SAS software and R,
- R Shiny analyzing the clinical trial data to produce the outputs for the clinical trial report;
- Prepare specifications and process flow diagrams, and develop programming code;
- Write specifications for the analysis datasets and report (Tables, Listings and Graphs) generation;
- Prepare reports to assist management in problem analysis, and submit recommendations for solution;
- Create primary and validation programs;
- Develop, test, debug and deploy the programs in coordination with other line functions as per standard operating procedures (SOPs);
- Maintain study documentation;
- Document and revise system design procedures, test procedures, and programming standards;
- Analyze user/customer needs and software requirements to determine feasibility of design within time and cost constraints;
- Create analysis files (datasets), and reports Tables, Listings and Figures;
- Consult with customers about software design, maintenance, enhancement and customization;
- Store, retrieve, and manipulate data for analysis and reporting;
- Expand or modify existing programs for efficiency and reusability; and Work on other ad hoc tasks as assigned.
- 3-5 years Pharma experience supporting clinical trials.
- Good understanding of Clinical Trial Data analysis.
- Experience with SAS, (R and R Shiny optional).
- Min. Bachelors' Degree
- MS in Comp. Science or any other related – preferred
- MS Biostat – Advanced SAS Certification required – can be verified via the Public Registry of SAS Certified Professionals – preferred