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 spans, 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 adapspan and flexible when priorities change
What you offer:
Bachelor’s 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 bachelor’s degree or equivalent. At least 6 years of related experience with a master’s 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 Rare diseases and Gastro Intestinal 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.
Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.