Principal Biostatistician

Company: Cytel Software Corporation
Location: Toledo
Posted on: May 27, 2023

Job Description:

As Principal Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies, with a focus on Neurological DisordersYou will contribute by:providing statistical support to clinical studies, with a focus on Neurological Disorders (Multiple Sclerosis, HIV, Alzheimers, Strokes, etc.);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 changeWhat were looking for:Masters 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 ofICH guidelines.Solidunderstanding & implementation of CDISC requirement for regulatory submissions.Adept in ADaM specifications generation and QC of datasets.Submissions experienceExperience 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 ambiguityWhats 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 developmentYou will be part of an exciting new chapter in Cytels history with high growth and opportunities to progress in Senior and Leadership positions within the companyWork in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementationWork with and leverage the best and brightest minds in the industryRequiredPreferredJob IndustriesCustomer Service

Keywords: Cytel Software Corporation, Toledo , Principal Biostatistician, Other , Toledo, Ohio