Principal Statistical Programmer FSP

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.

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