Technical Lead, Principal Statistical Programmer

Location: Aventura, FL, United States
Date Posted: 11-23-2016
  • Are you looking for an opportunity to build a world-class statistical programming group?
  • Are you driven by a quest for excellence, an ambition to succeed and an expectation that you will be rewarded for your efforts?
  • Wouldn’t you prefer to work in a location that is also a great place to live?
Biorasi is seeking an experienced Technical Lead as a Statistical Programmer to help extend our capabilities as an established, fast growing global CRO
… in sunny South Florida!
Job Summary:
Help to build and lead a team of SAS statistical programmers as they develop programs in support of clinical trials, produce analyses and generate outputs. Programming tasks will include support to data management for data validation and cleaning, SDTM and ADaM creation, TLF creation, ISS/ISE integration, as well as programming support for special projects and for drug safety.
Your primary task will be to guide and lead others in their statistical programming efforts, challenging them to grow and develop, while ensuring that we deliver the highest quality and best value services for our clients. Your SAS and clinical data skills will be sharp, and your ability to guide and communicate with others will be put to the test.
Primary Responsibilities:
  • Lead and guide statistical programming team in performing all SAS programming required for clinical trial analysis and reporting.
  • Provide statistical programming expertise for project teams.
  • Review the Statistical Analysis Plan in preparation for programming the planned analyses.
  • Design/develop SAS macros and other utilities to expedite SAS programming activities.
  • Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request.
  • Participate in statistical program validation and quality control activities.
  • Develop SDTM mapping documents; complete programming and validation of CDISC SDTM and ADaM datasets.
  • Actively participate in study team meetings.
  • Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects.
  • Mentor junior level statistical programmers.
Required Skills:
  • Strong analytical skills, with the ability to process scientific and medical data.
  • Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, SAS/Graph and SAS Macros.
  • Strong problem-solving skills.
  • Able to work independently.
  • Excellent knowledge of statistical programming.
  • Ability to identify data issues, present problems, and implement solutions.
  • Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues.
  • Good organizational and time management skills, with the ability to multi-task.
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines including FDA, EMA, ICH and GCP.
  • Understanding of CDISC SDTM and ADaM data models.
  • Strong interpersonal communication and presentation skills.
Education or Equivalent Experience:
  • Bachelor’s degree in computer science, statistics or other related, scientific field and five years of relevant professional experience (over 10 years preferred);
  • Alternatively an equivalent combination of relevant education and/or experience.
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