Senior Biostatistician FSP

Cytel - EMEA
London
2 months ago
Applications closed

Related Jobs

View all jobs

Senior Scientist, Pharmacoepidemiology & Safety

Senior Regulatory & Medical Writer - (12 Month FTC)

Senior Regulatory & Medical Writer - (12 Month FTC)

Senior Scientist, Pharmacoepidemiology & Safety

Senior Regulatory & Medical Writer - (12 Month FTC)

Senior Scientist, Pharmacoepidemiology & Safety

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 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.


RESPONSIBILITIES

As a Senior Biostatistician, your responsibilities will include:

  1. Providing statistical support to clinical studies
  2. Participating in the development of study protocols, including participation in study design discussions and sample size calculations
  3. Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications
  4. Performing statistical analyses and interpreting statistical results
  5. Preparing clinical study reports, including integrated summaries for submissions
  6. Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
  7. Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
  8. Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
  9. Participate in the development of CRFs, edit check specifications, and data validation plans
  10. Provide review and/or author data transfer specifications for external vendor data
  11. Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
  12. Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices


QUALIFICATIONS

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:

  1. Master’s degree in statistics or a related discipline. Ph.D. strongly desired.
  2. 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
  3. Experience working for a CRO is strongly desired.
  4. Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.
  5. Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.
  6. Solid understanding & implementation of CDISC requirements for regulatory submissions.
  7. Adept in ADaM specifications generation and QC of datasets.
  8. The ability to build strong external & internal relationships and motivate a regional or global team.
  9. Effective communicator: able to explain methodology and consequences of decisions in lay terms.

#J-18808-Ljbffr

Get the latest insights and jobs direct. Sign up for our newsletter.

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

Industry Insights

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

Tips for Staying Inspired: How Biotech Pros Fuel Creativity and Innovation

Biotechnology stands at the dynamic intersection of biology, technology, and engineering, shaping discoveries that redefine healthcare, agriculture, environmental protection, and more. Yet, long research timelines, strict regulatory frameworks, and constantly evolving knowledge can make it difficult to stay inspired. How do biotechnology professionals keep their creative drive alive in a field where each discovery could change the world—but also involves rigorous protocols and meticulous validation? Below, you’ll find ten practical tips for maintaining creativity and innovation in biotech. From launching side projects that test emerging methods to tapping into hackathons and reading the latest research, these strategies will help you cultivate fresh perspectives and invigorate your day-to-day work. Whether you’re a seasoned researcher, a newcomer to the lab bench, or someone navigating the business side of biotech, these insights can help sustain the passion you need to make a genuine impact.

Top 10 Biotech Career Myths Debunked: Key Facts for Aspiring Professionals

Biotechnology is an ever-evolving field at the crossroads of biology, chemistry, engineering, and data science. From developing life-saving therapies and vaccines to pioneering sustainable agricultural solutions, biotech careers encompass a breadth of opportunities that extend far beyond the confines of a research lab. Yet, despite its rapid growth and immense potential, myths and misconceptions continue to swirl around careers in biotechnology. At BiotechnologyJobs.co.uk, we see firsthand how inaccurate beliefs about entry requirements, salary expectations, or job security can discourage promising talent. It’s time to set the record straight. Whether you’re a biology undergraduate envisioning a future in research or a seasoned professional in another domain who’s curious about making the switch, this article will debunk the top myths surrounding biotech careers. We’ll examine why these misconceptions persist, and more importantly, reveal the dynamic and inclusive reality behind the industry’s cutting-edge work. So let’s separate fact from fiction. Read on to discover the genuine opportunities, roles, and progression pathways that await you in biotech.

Global vs. Local: Comparing the UK Biotech Job Market to International Landscapes

How to navigate opportunities, salaries, and work culture in biotechnology across the UK, the US, Europe, and Asia Biotechnology has steadily evolved from a specialised branch of life sciences to an influential force shaping healthcare, agriculture, environmental sustainability, and even digital technology through bioinformatics. From the development of groundbreaking gene therapies and vaccines to the engineering of sustainable biofuels and lab-grown foods, biotech has become one of the most innovative and impactful sectors worldwide. As such, the demand for skilled professionals—from research scientists to regulatory affairs experts—is on a steep upward trajectory. For job seekers looking to build or enhance their careers in biotechnology, understanding how different regional markets compare can be a game-changer. In this blog post, we examine how the UK biotech job market stacks up against that of the United States, Europe, and Asia. We’ll explore not only the scale of job demand and differences in salaries, but also important nuances around work culture and professional growth. For those considering remote or international positions, we’ll offer valuable insights to help you make informed decisions. Whether you’re a recent graduate from a life sciences programme, a seasoned researcher branching into industry, or a professional pivoting from a related discipline such as pharma or chemical engineering, the global biotech landscape is replete with opportunities. By assessing factors like salary expectations, cost of living, regulatory environments, and cultural norms, you’ll be better equipped to navigate the evolving biotech world—and thrive in a sector that’s reshaping our future.