As a leader in next generation, data-driven pharmaceutical services, Cytel is shaping the future of drug development. We deliver to the market innovative analytical software for statistical analysis and simulation, best-in-class data science analytics services and high-end impact consulting. Our culture is inclusive, collaborative and results-driven with a shared commitment to quality. With operations across North America, Europe, and India, Cytel hires passionate and talented people who share its mission of ensuring the clinical development of safe and effective medicines.
We are experiencing exponential growth on a global scale and hiring Senior Biostatisticians to lead or help drive one or more clinical studies, across a variety of therapeutic areas in our FSP division. You will report to the Senior Director, Biostatistics.
This is a home-based position in Europe, with the option to work from our Geneva, Basel, Paris and Barcelona office locations.
How you will contribute:
provide input into the study design, efficacy and safety parameters and the planned statistical analyses
perform the sample size calculations
help prepare / review clinical study reports, and provide input on interpretation of results and integrated summaries for submissions
respond to requests for the randomization schedule
review data management related documents and evaluate the quality of the database
author or review Statistical Analysis Plans (SAPs)
coordinate with other biostatisticians and statistical programmers to prepare the statistical analyses
participate in data review/evaluation meetings and other study-related meetings and activities
contribute and review abstracts, posters, presentations and manuscripts for publication and ensure accuracy of all biostatistical aspects of such documents
other duties may be assigned
What you offer:
· Master’s degree in statistics or a related discipline. PhD strongly desired.
· 3-5 years in supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
· 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 QC of datasets.
· Submissions experience
· Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
· 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
Meaningful Work, Collaborative Culture, Stimulating Challenges
Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
In addition to a competitive compensation, we offer an excellent benefits package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
Work with respected experts and thought leaders in the fields of biostatistics and statistical programming
Executive / senior industry position
Cambridge , United States