Principal Statistical Programmer

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 (TLF's)
• 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.