Senior Statistical Programmer FSP-Hybrid in PA

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer, you will be dedicated to one of our global pharmaceutical clients; a company that driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.

This is an exciting time to be a part of this new program.

As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Early or Late-stage clinical trials. This role is Hybrid office based in PA (Preferred) OR NJ.

• We believe in applying scientific rigor to reveal the full promise inherent in data.
• We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
• We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
• We prize innovation and seek intelligent solutions using leading-edge technology.

• Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK/PD Modeling and Simulation spanning all therapeutic areas
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• 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

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
• At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
• Having experience/expertise working on Early Development studies. Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).
• Develop and validate global programming standards for ADaM datasets.
• Develop and validate global programming standards for efficacy analysis, safety analysis and reporting.
• Design and develop complex programming algorithms.
• Experience in one or more of the following will be preferred: R, SPlus, Non Mem.
• Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
• Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.
• Up-versioning activities to specific versions of SDTM.
• Experience supporting Oncology studies would be a plus.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing the latest CDISC SDTM / ADaM standards.
• Knowledge of submission standards CDISC SDTM, Define.
  
  XML, SDRG, aCRF.
• Strong QC / validation skills.
• Good ad-hoc reporting skills.
• Proficiency in Efficacy analysis.
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
• Submissions experience utilizing define.xml and other submission documents.
• 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 / Aff…