Principal Statistical Programmer / Medical Affairs

The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality.

In this role, a typical day might include the following:

• Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Develop and maintain programming documentations and specifications following programming standards and processes


• Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management


• Support global regulatory authority submissions including preparing programming deliverable for submission and working closely with partnering functions to address health authority requests.
  
  Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. is a plus.


• Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus


• SAS, (Base, Stat, Macro, graph); SAS certificates a plus


To be considered for this opportunity you must have:

MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.

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