Principal Statistical Programmer

3 weeks ago


San Diego, United States Katalyst HealthCares & 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 . Apply 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 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 data Ability 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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