Clinical Statistical Programmer - Remote

W.L. Gore & Associates-posted 8 months ago
Full-time
Remote • Flagstaff, AZ
Miscellaneous Manufacturing
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We are looking for a Clinical Statistical Programmer to join our Medical team. In this role, you will primarily focus on developing, maintaining, documenting, and validating programs in support of Clinical investigations. This is a remote position, and you can work from home in most locations within the United States.

  • Program analysis datasets, statistical tables, listings and figures in support of Clinical for all phases of the Clinical endeavor in conjunction with biostatistician(s) and other programmer(s). This includes programming in accordance with specification documents and working independently to ensure independent validation.
  • Perform data exports and produce expected programmed output as-needed in support of Clinical investigations, making sure that expected outputs are delivered according to the needs of the team/regulatory.
  • Establish specifications for analysis datasets, summary tables and listings, which includes creating analysis dataset specifications and working with the biostatistician to confirm clarity.
  • Work closely with the Clinical team to formulate Case Report Forms (CRFs) with the goal to have the variables and the study database structure work effectively.
  • Produce clear, well-documented, and efficient programs with the knowledge to develop local macros and utilize global macros. Will also need to debug programs (including those written by other programmers) when necessary.
  • Sustain flexibility and efficiently use time available to support multiple studies at the same time, participating in team meetings and communicating with teams as-needed and prioritizing needs in conflict.
  • Research data issues and/or questions pertaining to the clinical study data, including identifying and assisting in meeting the programming needs of data management or other teams, as necessary.
  • Maintain knowledge of industry and regulatory trends and clinical trial terminology as required to meet business needs.
  • Comply with standard operating procedures (SOPs) and recommended policies, including training expectations for this role.
  • Participate in process improvement initiatives.
  • Bachelor's degree in a computer-related or research discipline or at least 5 years of significant SAS programming experience.
  • Minimum of 1 year of professional SAS programming experience.
  • Strong knowledge of SAS including: Base SAS, SAS Macro Language, SAS ODS facility, SAS GRAPH, and SAS STAT.
  • Strong verbal and written communication skills.
  • Enabled to work equally well independently and with teams.
  • Proven ability to work effectively in a fast-paced, team-oriented environment.
  • Ability to simultaneously support multiple clinical trial projects.
  • Ability to travel up to 5%.
  • Minimum of 2 years of SAS Programming experience in a clinical trial environment or comparable programming experience including familiarity with statistical analysis methods and terminology.
  • CDISC experience.
  • Other relevant experience (e.g. R programming, Power BI, dashboards, data analytics, process automation).
  • Comprehensive and competitive total rewards program.
  • Choice and flexibility in benefits promoting overall well-being.
  • Distinctive Associate Stock Ownership Plan.
  • Potential opportunities for profit-sharing.
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