Principal Statistical Programmer - Katalyst Healthcares & Life Sciences

• 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 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 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