Principal Statistical Programmer
2 weeks ago
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 guidelinesRequirements:
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/GraphExcellent knowledge of statistical programmingProficient in manipulating and analyzing SAS datbility to identify data issues, present problems, and implement solutions quicklyCapability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleaguesGood organizational and time management skills, with the ability to multi-taskFamiliarity 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 modelsVery strong interpersonal communication, presentation, and leadership skills
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