Job Description
As Principal Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies, with a focus on Neurology therapeutic area. This position reports to the Director of Biostatistics in FSP Services business unit in Cytel.
Responsibilities
You will contribute by:
* providing statistical support to clinical studies, with a focus on Neurology;
* 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
Qualifications
What we're looking for:
* Master's degree in statistics or a related discipline. PhD strongly desired.
* 5+ 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
* 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