Senior Biostatistician FSP

6 days ago

London, Greater London, United Kingdom Cytel Full time £60,000 - £100,000 per year
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:  

  • 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.
  • Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
  • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
  • Participate in the development of CRFs, edit check specifications, and data validation plans
  • Provide review and/or author data transfer specifications for external vendor data
  • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
  • 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:    

  • 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 with Early Phase activities such as dose escalation, dose finding, food effect, clinical pharmacology.
  • Experience with Bayesian models. 
  • Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions. 
  • Good SAS and R programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
  • 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.

  • Senior Biostatistician FSP

    4 days ago

    London, Greater London, United Kingdom Cytel Full time £60,000 - £120,000 per year

    Description Who Are You?    An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support our customer's HTA and launch activities. You are motivated to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical...

  • Senior Biostatistician FSP

    4 days ago

    London, Greater London, United Kingdom Cytel Full time £60,000 - £120,000 per year

    Description Who Are You?    An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support our customer's Health Technology Assessment (HTA) dossiers in Germany. You are motivated to do great work and collaborate easily with your clients. You never settle for what is,...

  • Principal Biostatistician FSP

    5 days ago

    London, Greater London, United Kingdom Cytel Full time £60,000 - £120,000 per year

    Description Who Are You?  An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never...

  • Principal Biostatistician FSP

    4 days ago

    London, Greater London, United Kingdom Cytel Full time £96,000 - £108,000 per year

    Description Who Are You?    An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead Phase III/IV clinical studies across your region including their medical affairs activities. . You are excited and enthusiastic, motivate your teams to do great work and...

  • Senior/Principal Biostatistician FSP

    1 week ago

    London, Greater London, United Kingdom Cytel Full time £80,000 - £110,000 per year

    Description Who Are You? A Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support 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...

  • Principal Biostatistician FSP

    2 days ago

    London, Greater London, United Kingdom Cytel Full time £72,000 - £144,000 per year

    DescriptionAs Principal Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies, with a focus on multiple therapeutic area with a focus on Rare Disease. ResponsibilitiesYou will contribute by:Providing statistical support to clinical studies, with a focus on Rare...

  • Senior Biostatistician

    6 days ago

    London, Greater London, United Kingdom Cytel Full time £60,000 - £120,000 per year

    DescriptionWho 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...

  • Senior / Principal Biostatistician

    2 weeks ago

    London, Greater London, United Kingdom Jobgether Full time £90,000 - £120,000 per year

    This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior / Principal Biostatistician in the United Kingdom.As a Senior / Principal Biostatistician, you will play a key role in designing and executing statistical strategies that support clinical research and the development of new therapies. You will lead...

  • Senior Biostatistician

    6 days ago

    London, Greater London, United Kingdom Lindus Health Full time £60,000 - £100,000 per year

    Our mission We're powering biology's century with radically faster, more reliable clinical trials. Every new treatment needs clinical trials to prove safety and efficacy, but today's infrastructure is stuck in the past- driving up cost, causing delays and ultimately meaning new treatments don't get to patients. We're fundamentally changing that- not just...

  • Senior Statistical Programmer FSP

    2 weeks ago

    London, Greater London, United Kingdom Axio Research Full time £60,000 - £120,000 per year

    Sponsor-dedicatedJob DescriptionWorking 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 Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient...