Engineer the Quantum RevolutionYour expertise can help us shape the future of quantum computing at Oxford Ionics.

View Open Roles

Principal Biostatistician

Cytel
1 year ago
Applications closed

Related Jobs

View all jobs

Principal Biostatistician

Principal Biostatistician

Principal Biostatistician, FSP - Permanent Homebased (m/w/d)

Principal Scientist Non-clinical PKPD

Principal Protein Scientist

Principal Investigator

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.

A Principal 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.

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 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 Principal 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.

To be successful in this position you will have:

Master’s degree in statistics or a related discipline. Ph.D. strongly desired. 8+ 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. Very effective communicator: able to explain methodology and consequences of decisions in lay terms.

Why Cytel?

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.

Our values

We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities We prize innovation and seek intelligent solutions using leading-edge technology.

How you will contribute:

Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures ( TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data Applying strong understanding/experience of Efficacy analysis Creating and reviewing submission documents and eCRTs Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties when called upon Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change

To be successful in this position you will have:

Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Submissions experience utilizing define.xml and other submission documents. Experience supporting Rare diseases and Gastro Intestinal studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

Why Cytel?

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.

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Seasonal Hiring Peaks for Biotechnology Jobs: The Best Months to Apply & Why

The UK's biotechnology sector has evolved into one of Europe's most dynamic and lucrative career markets, with roles spanning from laboratory research to regulatory affairs and bioprocessing engineering. With biotech positions commanding salaries ranging from £28,000 for entry-level research associates to £95,000+ for senior directors, understanding when companies actively recruit can significantly enhance your job search success. Unlike traditional industries, biotechnology hiring follows distinct seasonal patterns driven by research funding cycles, regulatory submission deadlines, and academic collaboration timelines. The sector's unique blend of scientific rigour, commercial pressure, and regulatory oversight creates predictable hiring windows that savvy professionals can leverage to advance their careers. This comprehensive guide explores the optimal timing for biotechnology job applications in the UK, examining how funding announcements, clinical trial phases, and academic calendars influence when companies expand their teams and why strategic timing can make the difference between landing your ideal role and missing the opportunity entirely.

Pre-Employment Checks for Biotechnology Jobs: DBS, References & Right-to-Work and more Explained

The biotechnology sector in the UK continues to flourish as one of the world's leading life sciences hubs, with companies ranging from cutting-edge gene therapy startups to established pharmaceutical giants seeking talented professionals. However, securing a position in this highly regulated and security-conscious industry involves comprehensive pre-employment screening that goes far beyond typical recruitment processes. Whether you're a research scientist, bioprocess engineer, regulatory affairs specialist, or clinical trial manager, understanding the extensive vetting requirements is essential for successfully navigating your career in biotechnology. This comprehensive guide explores the various background checks and screening processes you'll encounter when applying for biotech positions in the UK, from basic eligibility verification to stringent security and regulatory compliance assessments.

Why Now Is the Perfect Time to Launch Your Career in Biotechnology: The UK's Life Sciences Renaissance

The United Kingdom stands at the precipice of a biotechnology revolution that promises to reshape medicine, agriculture, manufacturing, and environmental sustainability for generations to come. From the gene therapy pioneers in Oxford to the synthetic biology innovators in Cambridge, Britain's biotech sector is experiencing unprecedented growth, creating extraordinary opportunities for career changers and new graduates alike. If you've been contemplating a move into biotechnology, the stars have never been more perfectly aligned. The convergence of scientific breakthroughs, government investment, industry expansion, and societal need has created a career landscape rich with possibility and purpose.