Cytel is shaping the future of drug development. As the world's largest independent clinical biostatistics research and development organization, we help leading pharmaceutical, biotech and medical device companies improve clinical success rates via optimal study design, effective data management, accurate statistical analysis and software. With operations across North America, Europe, and India, we are always on the lookout for passionate and talented people who share our mission of ensuring the clinical development of safe and effective medicines.
We are growing and hiring remote Principal and Senior Biostatisticians, for both permanent and contract positions, to join our clinical research services division. You will be adept at utilizing advanced statistical methods, to lead or help drive one or more Phase I-IV clinical studies, supporting a variety of therapeutic areas.This position reports to the Sr. Director, Biostatistics.
Position is home-based in Europe, however ideally located in any of these countries; UK, Switzerland, France, Barcelona, Czech Republic, or Germany.
Option to work from our offices in Paris, Barcelona, Geneva or Basel.
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.
* 3+ 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 QC of datasets.
* Submissions experience
* 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
* 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 benefit's 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.
T: +44 (0)1444242220
M: +44 (0) 7709674055
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