[Hiring] Senior Biostatistician @Cytel Inc

Role Description

An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic, motivating your teams to do great work and collaborating easily with clients. You never settle for what is, but always push clinical development forward to what it could be.

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician, you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Our Senior Biostatisticians perform ad-hoc or exploratory analyses to support submission or Health Authority Questions. Having exposure to regulatory work experience is a bonus, for example, if you understand the regulatory questions and translating them to statistical problems, collaborating effectively with clinical and regulatory colleagues. Supporting medium complexity clinical trials (starting from Design to Archival experience) and supporting 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 dataset 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
• Understanding and following FDA regulations which affect the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissions
• Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participating in the development of CRFs, edit check specifications, and data validation plans
• Providing review and/or author data transfer specifications for external vendor data
• Collaborating with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Providing 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
• The ability to build strong external & internal relationships and motivate a regional or global team
• Effective communicator: able to explain methodology and consequences of decisions in lay terms