Principal Statistical Programmer FSP

3 weeks ago


Toronto, Canada Cytel Full time

Key Responsibilities: Provide technical leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures , and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor Provide technical leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission Ensure compliance with company SOP'S and FDA/ICH/GCP regulations Perform quality control checks of advanced SAS code for datasets and output produced by other statistical programmers Review, maintain study documents per standard process Program, test, and document global utility programs and tools in accordance with standards and validation procedures Conduct briefings and participate in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects Perform lead duties when called upon Perform other duties as assigned Technical and Communication Skills: Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH R programming experience is a plus Excellent and transparent communication skills and ability to interact across multiple functions Adaptability and flexibility for when priorities change Preferred Education and Experiences: MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry, or BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical industry Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. #J-18808-Ljbffr



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