Principal Statistical Programmer FSP - Medical Affairs and Clinical Development
Cytel
The Principal Statistical Programmer will develop, maintain, validate and run SAS computer programs that access, visualize, analyze, and report clinical trial or registry data in accordance with statistical analysis plans. Ability to work independently and strong SAS/GRAPH programming experience is required. Ability to comprehend complex programming concepts with minimal guidance is also required.
The position reports to the AD or Director of Statistical Programming.
Key Responsibilities:
+ Write SAS programs that produce tables, listings, figures and analysis datasets ;
+ Write SAS programs that validate tables, listings, figures, and analysis datasets;
+ Follow good programming practices, including adequately documenting SAS code;
+ Use, modify, and maintain existing SAS code;
+ Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
+ Assist in developing programming processes consistent with industry best practices;
+ Review DMP, eCRF specs, and other clinical data management documents;
+ Review statistical analysis plans and other related documents;
+ Partner with CRO to perform any of the above tasks;
+ Perform all the tasks with minimal instruction or input from supervisor
+ Review, maintain study documents per standard process
+ Program, test, and document global utility macros and tools in accordance with standards and validation procedures
+ 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 shiny experience is a plus
+ Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
+ Excellent and transparent communication skills and ability to represent the functional group to across stakeholders
Comfortable with quick turnaround and able find an optimum solution for a given problem
Qualifications
+ At least 10 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
+ Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
+ Experience in producing and validating SAS programs;
+ Experience in working with CDISC standards, including SDTM, and ADaM;
+ Familiarity with statistical analysis for standard clinical trial outputs;
+ Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
+ Good communications skills required;
+ Bachelor’s Degree required, Master’s Degree Preferred.
+ Clear alignment with the Core Values:
+ Commitment to People
+ Innovation and Discovery
+ Sense of Urgency
+ Open Culture
+ Passion for Excellence
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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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