Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.
As Principal Biostatistician, you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more Phase I-IV trials, with a focus Infectious Disease studies.
You will contribute by:
What we are looking for:
Master's degree in statistics or a related discipline. PhD strongly desired.
8-10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
Experience in Early Development studes desired.
3-5 years of Study Lead experience working with cross-functional teams.
Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
Knowledge and implementation of advanced statistical methods.
Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
Strong knowledge of ICH guidelines.
Solid understanding & implementation of CDISC requirement for regulatory submissions.
Adept in ADaM specifications generation and programmatic review of datasets.
Submissions experience (ISS/ISE) strongly desired.
Effective communicator: able to explain methodology and consequences of decisions in lay terms.
Team player; willingness to go the extra distance to get results, meet deadlines, etc.
Ability to be flexible when priorities change and deal with ambiguity.
What's in it for you:
You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development.
You will be part of an exciting new chapter in Cytel's history with high growth and opportunities to progress in Senior and Leadership positions within the company.
Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
Work with and leverage the best and brightest minds in the 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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