Description :

How you will contribute :

- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming.

- Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).

- Production and QC / validation programming.

- Generating complex ad-hoc reports utilizing raw data.

- Applying strong understanding/experience of Efficacy analysis.

- Creating and reviewing submission documents and eCRTs.

- Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries.

- Performing lead duties when called upon.

- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.

- Being adaptable and flexible when priorities change.

Qualifications :

- To be successful in this position you will have :

- Bachelors degree in one of the following fields Statistics, Computer Science, Mathematics, etc.

- At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelors degree or equivalent.

- At least 6 years of related experience with a masters degree or above.

- Study lead experience, preferably juggling multiple projects simultaneously preferred.

- Strong SAS data manipulation, analysis and reporting skills.

- Solid experience implementing the latest CDISC SDTM / ADaM standards.

- Strong QC / validation skills.

- Good ad-hoc reporting skills.

- Proficiency in Efficacy analysis.

- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data.

- Submissions experience utilizing define.xml and other submission documents.

- Experience supporting immunology, respiratory or oncology studies would be a plus.

- Excellent analytical & troubleshooting skills.

- Ability to provide quality output and deliverables, in adherence with challenging timelines.

- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.