As a Principal 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, tables, 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 adaptable and flexible when priorities change
What we're 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.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
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