As aPrincipal Statistical Programmer, you will lead studies and programmers, provide mentorshiop, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular or Medical Affairs. You will report to the Director, Statistical Programming.
Additionally, you will contribute by:
- performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
- applying your CDISC know-how and proficiency in SDTM and ADaM, to create and validate datasets/analysis files, spans, listings, and figures (TLFs);
- generating complex ad-hoc reports
- preparing and validating submission packages, i.e. define.xml, Reviewers Guide
- applying your strong understanding/experience with Efficacy analysis;
- preparing submission packages
- 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 were looking for:
- Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- Minimum 7 years of SAS programming experience in the Pharmaceutical & Biotech industry.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Study programming lead experience
- Strong SAS data manipulation, analysis and reporting skills.
- Ability to implement the latest CDISC SDTM / ADaM standards (production/validation).
- Proficiency in SAS MACRO development
- Strong ad-hoc reporting
- Solid experience in Efficacy analysis
- Experience with Pinnacle21
- Submissions experience utilizing define.xml and other submission documents.
- Experience supporting Medical Affairs, Immunology, Cardiovascular or Oncology strongly desirable.
- 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.