Senior Biostatistician
4 weeks ago
Summary of Job Responsibilities:• providing statistical support to clinical studies• participating in the development of study protocols, including participation in study design discussions and samplesize calculations• reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis datasetand TLG specifications• performing statistical analyses• interpreting statistical results• preparing clinical study reports, including integrated summaries for submissions• utilizing your strong communication skills to present and explain the methodology and consequences of decisions in layterms• serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.; beingadaptable and flexible when priorities change
Qualifications and Experience:• Master’s degree in statistics or a related discipline. Ph.D. strongly desired.• 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO is 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 is a plus.• Strong knowledge of ICH guidelines.• Solid understanding & implementation of CDISC requirements 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.
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