US 100% Remote Principal Biostatistician FSP

Cytel; Lincoln (NE); Remote; USD 140,000 - 190,000; Full time

Job summary

Cytel Inc. is seeking a Principal Biostatistician to lead statistical support for Phase I–IV trials within our client program.

You will drive study design, analyses, and interpretation, collaborating with cross-functional teams and external vendors to deliver regulatory-ready results. The ideal candidate holds a Master's or PhD in statistics, with 8–10 years in biostatistics, strong R and SAS skills, and proven leadership in study leads and regulatory submissions.

Qualifications

• Master's degree in Statistics, Biostatistics, or related; PhD strongly preferred.
• 8-10 years of biostatistics experience in clinical trials; CRO experience preferred.
• 3-5 years of Study Lead experience with cross-functional development teams.
• Extensive experience in study design, SAP development, efficacy analyses, and regulatory submissions.
• Strong knowledge of advanced statistical methods including mixed models and simulations.
• Ability to perform exploratory analyses to support clinical development decisions.
• Proficiency in R for analyses, simulations, and data visualization.
• Solid SAS programming skills and collaboration with Statistical Programmers.
• Knowledge of ICH guidelines and regulatory expectations.
• CDISC standards implementation for regulatory submissions.
• Experience generating ADaM specs and reviewing analysis datasets.
• Regulatory submission experience (ISS/ISE) strongly desired.
• Excellent communication to explain statistics to varied audiences.
• Collaborative mindset to deliver high-quality work under tight timelines.
• Ability to thrive in a dynamic environment and adapt to changing priorities.

Responsibilities

• Participate in study protocol development, design discussions, and sample size calculations.
• Lead exploratory data analyses to evaluate study trends and support scientific decisions.
• Apply advanced methods, including mixed models, for efficacy and longitudinal analyses.
• Design and execute simulation studies to evaluate designs and operating characteristics.
• Lead efficacy analyses and interpretation of primary and secondary endpoints.
• Review CRFs and develop SAPs, including analysis datasets and TLF specifications.
• Perform statistical analyses and interpret results.
• Provide strategic statistical guidance to cross-functional teams.
• Present statistical methodology and implications clearly to non-technical audiences.
• Collaborate with teams to meet project goals and timelines.
• Demonstrate adaptability as project priorities evolve.

Skills

Biostatistics

Study lead

Statistical modeling

R

SAS

Data analysis

Education

Master's degree in Statistics/Biostatistics or related; PhD strongly preferred

PhD preferred

Tools

R

SAS

Job 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 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.

Cytel Inc. is an Equal Employment / Aff…?