Principal Statistical Programmer

2 weeks ago


San Diego, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities
  • Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity .
  • pply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams.
  • Review the Statistical Analysis Plan in preparation for programming the planned analyses.
  • Lead design/development of SAS macros and other utilities to expedite SAS programming activities.
  • Organize and conduct internal training sessions and author papers for conferences.
  • 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 or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets.
  • Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines
Requirements:
  • 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 Macros and SAS/Graph
  • Excellent knowledge of statistical programming
  • Proficient in manipulating and analyzing SAS dat
  • bility to identify data issues, present problems, and implement solutions quickly
  • 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 (FDA/CFR, ICH/GCP). Expert knowledge of CDISC SDTM and ADaM data models
  • Very strong interpersonal communication, presentation, and leadership skills


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