Job Description

**Who Are You?** 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 II-III clinical studies. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same. **Sponsor-dedicated:** 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. **Position Overview:** Our Senior Biostatisticians support the full trial analyses and 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. **As a Senior Biostatistician, your responsibilities will include:** + 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. + Participate in the development of CRFs, edit check specifications, data transfer specifications, and data validation plans. + Performing statistical analyses and interpreting statistical results. + Preparing clinical study reports, including integrated summaries for submissions. + Prepare submission packages in collaboration with the programming team. + Perform ad hoc analyses for regulatory requests and publication activities. + Utilizing your 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. This includes good clinical practice and guidelines for electronic submissions. + Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals **Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:** + 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 or pharmaceutical company is strongly desired. + Experience in oncology clinical trials; haematology preferred, but not required. + Experience with time-to-event analyses. + Experience in sample size calculation, protocol development, SAP, preparing clinical study reports including integrated summaries, and preparing submission packages. + 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. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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