Sanofi Vx - Senior Biostatistician

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development., Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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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Ihre Aufgaben

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.

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

• Performing statistical analyses and 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.

Ihr Profil

A Senior 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. 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.,

• 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.