Job Responsibilities :
- Processing of clinical data required for analysis of company clinical trials.
- Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
- Program SAS to integrate and reconcile data from external sources for past, current and future planned clinical trials.
- Generate SAS code to help automate weekly reports created by the Clinical Research team.
- Generate and quality-check summary tables, data listings and graphs for in-house analyses of study data for publications using SAS standard coding practices.
- Create/acquire tools to improve programming efficiency or quality. Validate work of other programmer/analysts and statisticians.
- Assist in the creation/review of data management plans, specifications for datasets and annotated eCRFs.
- Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
- Support data queries from other functional groups (Technology, Production, Regulatory, and Marketing).
- Assist in the development of[AW1] , data-entry and data handling guidelines/SOPs, eCRFs and other study support documentation.
Skills Needed :
- Familiarity with CDISC/ Study Data Tabulation Model (SDTM).
- Excellent knowledge of SAS programming and associated features and their applications in medical device research and in particular, a clinical trial data setting.
- Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
- Willingness to help out in other areas of clinical research, trial design and planning, trial management, data management, and report writing.
- Track record of generating new ideas and solutions to data analysis.
- Thorough understanding of relational database components and theory.
- Excellent oral and written communication skills.
- Familiarity with ICH/GCP and 21 CFR part 11.
- Some travel required; will occasionally conduct site visits, attend investigator meetings or vendor visits/audits.
Educational Requirements & Work Experience:
- A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas is required. Statistics degree and strong understanding preferred.
- A minimum of 2 years hands on relevant career experience in the pharmaceutical, medical device or biotechnology industry.
- SAS certification (v9.2 or later).