Principal Biostatistician FSP

Posted 2 Hours Ago
Be an Early Applicant
2 Locations
In-Office or Remote
Mid level
Software • Analytics • Biotech
The Role
Provides statistical support for Phase I–IV clinical studies, including study design, sample size calculations, protocol development, CRF and data review, SAPs, ADaM specifications, statistical analyses, clinical study reports, and regulatory submissions. Collaborates with clinical, regulatory, programming, pharmaceutical, and biotechnology teams while explaining statistical methods and results to stakeholders.
Summary Generated by Built In
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 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 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: 

As a Biostatistician, you’ll 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.


Responsibilities

As a 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.
QualificationsHere 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.
  • 3+ 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.

Skills Required

  • Master's degree in statistics or a related discipline
  • Ph.D. in statistics or a related discipline
  • 3+ years supporting clinical trials in the pharmaceutical or biotechnology industry
  • Experience working for a contract research organization (CRO)
  • Experience with sample size calculations and protocol concept or protocol development
  • Experience developing statistical analysis plans (SAPs)
  • Experience preparing clinical study reports, including integrated summaries for submissions
  • Strong SAS programming skills for quality control of critical outputs and efficacy and safety tables
  • Knowledge of R programming
  • Understanding and implementation of CDISC requirements for regulatory submissions
  • Experience generating and quality-checking ADaM specifications and datasets
  • Ability to build strong external and internal relationships and motivate regional or global teams
  • Effective communication skills, including explaining statistical methodology and decisions in lay terms

Cytel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.

  • Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
  • Retirement Support — A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
  • Fair & Transparent Compensation — Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.

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The Company
HQ: Cambridge, MA
1,395 Employees
Year Founded: 1987

What We Do

Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com

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