Principal Biostatistician FSP - Pre-clinical studies

As a Principal Biostatistician, you are responsible for statistical activities in support of pre‑clinical trials, including assay qualification, dose‑response analysis, data visualization,

• 
  
• Provide statistical leadership and statistical expertise into pre‑clinical studies, represent Cytel and the statistical team on the Development Teams of sponsors.
  
• Lead statistical activities on assigned projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across multiple projects.
  
• Provide statistical input into study concept, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
  
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
  
• When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
  
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
  
• Contribute to the development of sourcing strategy for projects.
  
• Develop strong collaboration and communication with sponsor cross‑functional teams and sponsor Biostatistics management.
  

• 
  
• Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.
  
• At least 6 years of experience as biostatistician in the Pharmaceutical/Biotechnology industry in clinical development/non‑clinical studies.
  
• At least 3 years of experience as a Lead Biostatistician for clinical/non‑clinical projects.
  
• Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data submission to FDA.
  
• Fluent in English.
  
• Working SAS & CDISC knowledge.
  

• 
  
• Works effectively in international teams, effectively operates within a matrix organization and with multi‑disciplinary groups.
  
• Understands and anticipates customer needs and responds to their inquiries.
  
• R coding, mixed models, flexible in approach, scientific curiosity, excellent at data visualization.
  
• Able to work on multiple projects.
  
• Experienced with assay qualification and dose‑response analysis.
  
• Verbal and written communication is effective with multi‑disciplinary groups.
  
• Work is well‑organized, of high‑quality, meeting timelines. Able to balance concurrent tasks and responsibilities.
  
• Excellent time management.
  
• Brings creative ideas and makes suggestions for optimization.
  
• Exhibits leadership for the biostatistics team working on the same clinical development teams.
  
• Exhibits the ability to mentor and develop statistical colleagues.
  

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.