Principal Statistical Programmer

As a Principal Statistical Programmer, 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, Infectious Disease, Early Development, or Medical Affairs. 

• Must have Oncology TA experience
• 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 Safety and Efficacy 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, Pinnacle 21
• 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

Qualifications and Experience:

• BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
• Must have relevant industry experience
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
• Strong SAS data manipulation, analysis and reporting skills.
• Ability to implement the latest CDISC ADaM standards (production/validation). ADaM efficacy dataset development is required.
• Familiarity with pooled data such as in an ISS or ISE or other pooled studies dataset. Experience is preferred but not required.
• Proficiency in SAS  MACRO development
• Strong ad-hoc reporting   
• Solid experience in Efficacy analysis
• Experience and or familiar with Pinnacle21
• Submissions experience utilizing define.xml and other submission documents such as SDRG, ADRG
• Experience supporting Medical Affairs, Immunology, Cardiovascular, Oncology, Infectious Disease are strongly desirable. Oncology knowledge of efficacy endpoints is also desired. 
• 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.