Lead Biometrician
1 week ago
Job OverviewCytel is seeking a highly skilled Principal Statistical Programmer to work closely with our global pharmaceutical clients. As the ideal candidate, you will be embedded within their team and play a key role in driving innovation.This role presents an exciting opportunity to contribute to the success of the Sponsor clinical trials. You will be responsible for implementing all reporting and analysis activities, including generating SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.Key responsibilities will include: developing SAS programs, delivering high-quality statistical programming results, participating in overseeing CRO's statistical programming deliverables, supporting the preparation of clinical study reports, regulatory submissions, publications and exploratory analyses.To excel in this position, you must possess a deep understanding of FDA regulations affecting the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissions.RequirementsAt least a bachelor's degree in computer science, data science, mathematics or statistics major preferred7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar team experience supporting drug development, medical device development or intervention studiesExceptional SAS programming skills and expertise in developing and implementing statistical programming procedures and processes in a clinical development environmentNote: This role requires strong technical expertise, excellent analytical skills and a high level of professionalism.