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 looking for multiple Principal Biostatisticians to be based in one of our offices.
How you will contribute:
· providing statistical support to clinical studies;
· participating in the development of study protocols, including participation in study design discussions and sample size calculations;
· reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
· performing statistical analyses;
· interpreting statistical results;
· preparing clinical study reports, including integrated summaries for submissions;
· leading study activities when called upon;
· utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
· serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
· being adaptable and flexible when priorities change
What you offer:
· Master’s degree in statistics or a related discipline. PhD strongly desired.
· 5-10 years 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
· Study lead 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