Principal Statistical Programmer

Cytel - USA - 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.... - Permanent - Full-time

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