Senior Lead Statistical Programmer

5 hours ago


Carlsbad, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • You will provide technical expertise as an experienced R programmer to develop process methodology, ensuring the department meets the needs of both internal and external clients.
  • Responsibilities include planning and coordinating the development of integrated programming solutions across a broad range of statistical programming requirements.
  • you will also provide technical leadership and internal consulting services, providing specifications and conducting user needs analysis for complex projects or specific client requirements.
  • Expertise in R programming and SAS Base, with good knowledge of SAS Graph and SAS Macros.
  • Ability to implement advanced statistical procedures based on biostatistician specifications.
  • Excellent application development skills with extensive experience in clinical trial data manipulation, analysis, and reporting.
  • Strong knowledge of relational database components and theory.
  • Perform all responsibilities associated with the Senior Programmer role.
  • Assist Senior Programmers and Programmers in their daily activities.
  • Act as the escalation point for Senior Programmers and Programmers.
  • Regularly communicate with sponsors regarding the programming aspects of the project, anticipating issues proactively and collaborating on resolutions.
  • Provide input and/or write programming specifications.
  • Serve as a subject matter expert on all aspects of SAS and R programming.
  • Develop consistent practices for clinical and statistical review of outputs, mentoring programming staff.
  • Ensure consistency across therapeutic areas and oversee the implementation of process improvement initiatives.
  • Maintain expertise with SAS Macros & R and prioritize macro development.
Requirements:
  • Experience as a technical team lead, directly engaging clients and coordinating tasks within a programming team.
  • In-depth knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and ICH guidelines.
  • Advanced knowledge of R programming, SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL.
  • Familiarity with SDTM and Adam implementation in accordance with CDISC standards.
  • Strong organizational, interpersonal, leadership, and communication skills.
  • Ability to independently manage tasks and projects while delegating work to team members.
  • Excellent attention to detail and problem-solving abilities.
  • Bachelor's degree required, preferably in science or mathematics-related fields.
  • Minimum of 5 years of experience in statistical programming in the pharmaceutical or medical device industry.
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