Overview
Our Senior Biostatisticians perform ad-hoc or exploratory analyses to support submission or Health Authority questions. Exposure to regulatory work is a bonus, for example, translating regulatory questions into statistical problems and collaborating effectively with clinical and regulatory colleagues. They support medium complexity clinical trials (from design to archival experience) and participate in some project-level activities.
Responsibilities
* 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 datasets and TLG specifications
* Performing statistical analyses and interpreting statistical results
* Preparing clinical study reports, including integrated summaries for submissions
* Utilizing strong communication skills to present and explain the methodology and consequences of decisions
* Understand and follow FDA regulations which affect the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissions
* Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
* Participate in the development of CRFs, edit check specifications, and data validation plans
* Provide review and/or author data transfer specifications for external vendor data
* Collaborate with internal and external functions (e.g., CROs, software vendors, clinical development partners) to meet project timelines and goals
* Provide review and/or author SOPs and/or work instructions related to statistical programming practices
Qualifications
* 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
* Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers; knowledge of R programming is a plus
* Solid understanding & implementation of CDISC requirements for regulatory submissions
* Adept in ADaM specifications generation and QC of datasets
* Ability to build strong external and internal relationships and motivate a regional or global team
* Effective communicator: able to explain methodology and consequences of decisions in lay terms
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