The Role
Lead statistical design and analysis for Phase I-IV clinical studies, develop protocols and SAPs, perform efficacy and exploratory analyses, run simulations, apply advanced methods (mixed models, longitudinal), oversee datasets (ADaM/CDISC), use R and SAS for analyses, and provide strategic statistical guidance to cross-functional teams supporting regulatory submissions.
Summary Generated by Built In
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 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:
Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
- Participating in the development of study protocols, including study design discussions and sample size calculations.
- Participating in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout the course of development.
- Applying advanced statistical methodologies, including mixed models and other complex modeling techniques, to support efficacy and longitudinal analyses.
- Designing and executing simulation studies to evaluate study designs, operating characteristics, and statistical methodologies.
- Leading and contributing to efficacy analyses and interpretation of primary and secondary endpoints.
- Reviewing CRFs and data review guidelines; developing Statistical Analysis Plans (SAPs), including analysis dataset and TLF specifications.
- Performing statistical analyses and interpreting statistical results.
- Leading study activities when called upon and providing strategic statistical guidance to cross-functional teams.
- Utilizing strong communication skills to present statistical methodology, assumptions, and the implications of decisions in clear, non-technical language.
- Serving as a collaborative team player with a willingness to go the extra distance to meet project goals and timelines.
Demonstrating adaptability and flexibility as project priorities evolve.
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, Biostatistics, or a related discipline. PhD strongly preferred.
- 8-10 years of biostatistics experience supporting clinical trials within the pharmaceutical or biotechnology industry. CRO experience strongly preferred.
- 3-5 years of Study Lead experience working with cross-functional development teams.
- Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE).
- Strong knowledge and practical application of advanced statistical methods, including mixed models, longitudinal analyses, and simulation methodologies.
- Demonstrated experience performing exploratory statistical analyses to support clinical development and decision-making.
- Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling.
- Solid SAS programming skills, including QC of critical outputs, efficacy and safety tables, and close collaboration with Statistical Programmers.
- Strong knowledge of ICH guidelines and regulatory expectations.
- Solid understanding and implementation of CDISC standards for regulatory submissions.
- Experience generating ADaM specifications and performing programmatic review of analysis datasets.
- Regulatory submission experience (ISS/ISE) strongly desired.
- Excellent communication skills with the ability to explain statistical methodology and its implications to both technical and non-technical audiences.
- Strong collaborative mindset with a commitment to delivering high-quality work under tight timelines.
- Ability to thrive in a dynamic environment, manage ambiguity, and adapt to changing priorities.
Skills Required
- Master's degree in Statistics, Biostatistics, or related discipline
- PhD in Statistics/Biostatistics (strongly preferred)
- 8-10 years of biostatistics experience supporting clinical trials in pharmaceutical or biotechnology industry
- CRO experience
- 3-5 years of Study Lead experience with cross-functional development teams
- Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and clinical study reports (ISS/ISE)
- Strong knowledge and practical application of advanced statistical methods (mixed models, longitudinal analyses, simulation methodologies)
- Demonstrated experience performing exploratory statistical analyses to support clinical development
- Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling
- Solid SAS programming skills including QC of critical outputs, efficacy and safety tables
- Strong knowledge of ICH guidelines and regulatory expectations
- Solid understanding and implementation of CDISC standards for regulatory submissions
- Experience generating ADaM specifications and performing programmatic review of analysis datasets
- Regulatory submission experience (ISS/ISE)
- Excellent communication skills to explain statistical methodology to technical and non-technical audiences
- Ability to work collaboratively under tight timelines and adapt to changing priorities
- Experience with machine learning and deep learning algorithms for data mining and automation
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.
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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.
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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.
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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
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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