As Principal Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies specially focusing on Alzheimer’s and Type 2 Diabetes.
ResponsibilitiesAs a Principal Biostatistician, your responsibilities include:
- providing statistical support to clinical studies, with a focus on Hypertension;
- 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;
- interpreting statistical results;
- preparing clinical study reports, including integrated summaries for submissions;
- leading study activities when called upon;
- utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
- serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
- being adaptable and flexible when priorities change
What we’re looking for:
- Master’s degree in statistics or a related discipline. PhD strongly desired.
- 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
- Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
- Knowledge and implementation of advanced statistical methods.
- Good SAS and R programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
- Strong knowledge of ICH guidelines.
- Solid understanding & implementation of CDISC requirement for regulatory submissions.
- Adept in ADaM specifications generation and QC of datasets.
- Submissions experience.
- Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- Team player; willingness to go the extra distance to get results, meet deadlines, etc.
- Ability to be flexible when priorities change and deal with ambiguity.
Skills Required
- Master's degree in statistics or a related discipline
- PhD in statistics or related discipline
- 5+ years supporting clinical trials in the pharmaceutical or biotechnology industry
- Experience working for a CRO
- Experience in sample size calculation, protocol concept and protocol development, SAP and preparing clinical study reports including integrated summaries
- Knowledge and implementation of advanced statistical methods
- Proficient SAS programming skills for QCing critical outputs and tables
- R programming skills
- Strong knowledge of ICH guidelines
- Solid understanding and implementation of CDISC standards for regulatory submissions
- Adept in ADaM specification generation and QC of datasets
- Submissions experience (regulatory submissions)
- Experience working with cross-functional teams or Study Management Teams
- Effective communication: explain methodology and consequences in lay terms
- Team player with willingness to meet deadlines and adapt to changing priorities
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
