Will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation. This person will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
ResponsibilitiesParticipate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
Collaborate with cross-functional team members to meet study any recurring report timelines.
Support the development and implementation of study protocols.
Review and provide input to data capture systems and participate in their validation.
Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents.
Respond to statistical questions from regulatory agencies.
QualificationsMS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 7 years of experience in pharmaceutical or biotechnology industry.
PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
Knowledge of drug development regulations pertinent to statistical analysis.
Knowledge of the oncology or hematology therapeutic area is preferred.
Bayesian and adaptive design experience is preferred.
Proficient SAS & R programming skills, solid understanding of CDISC models and standards.
Excellent writing and communication skills.
Demonstrated leadership abilities and excellent interpersonal skills.
Skills Required
- MS or MPH in statistics, mathematics, or related discipline with statistical focus and >7 years pharmaceutical/biotechnology experience
- PhD in statistics, mathematics, or related discipline with statistical focus and >2 years pharmaceutical/biotechnology experience
- Knowledge of drug development regulations pertinent to statistical analysis
- Proficient SAS programming skills
- Proficient R programming skills
- Solid understanding of CDISC models and standards
- Experience designing and reporting Phase I-IV clinical studies and regulatory filings
- Ability to develop statistical programs to simulate trial designs, perform analyses, prepare displays, and validate results
- Excellent writing and communication skills
- Demonstrated leadership abilities and excellent interpersonal skills
- Knowledge of the oncology or hematology therapeutic area
- Bayesian and adaptive design experience
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.
Cytel Insights
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
