US 100% Remote Principal Biostatistician FSP-Must have R proficiency

About the Role

As a Principal Biostatistician, you will lead Phase I-IV clinical studies, driving innovation and excellence in clinical development. Working fully embedded within a global pharmaceutical client, you will provide statistical and development support, influencing clinical development plans, protocols, and strategic decision-making. This role offers autonomy and ownership within an exciting, forward-thinking program.

Responsibilities

• Participate in the development of study protocols, including study design discussions and sample size calculations.
• Conduct exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout development.
• Apply advanced statistical methodologies, such as mixed models and complex modeling techniques, to support efficacy and longitudinal analyses.
• Design and execute simulation studies to evaluate study designs, operating characteristics, and statistical methodologies.
• Lead and contribute to efficacy analyses and interpretation of primary and secondary endpoints.
• Review CRFs and data review guidelines; develop Statistical Analysis Plans (SAPs), including analysis dataset and TLF specifications.
• Perform statistical analyses and interpret results.
• Lead study activities and provide strategic statistical guidance to cross-functional teams.
• Communicate statistical methodology, assumptions, and implications in clear, non-technical language.
• Collaborate effectively to meet project goals and timelines, demonstrating adaptability as priorities evolve.

Qualifications

• Master’s degree in Statistics, Biostatistics, or a related discipline; PhD strongly preferred.
• 8–10 years of biostatistics experience supporting clinical trials in 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.
• 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 collaboration with Statistical Programmers.
• Strong knowledge of ICH guidelines and regulatory expectations.
• Understanding and implementation of CDISC standards for regulatory submissions, including generating ADaM specifications and reviewing analysis datasets.
• Regulatory submission experience (ISS/ISE) strongly desired.
• Excellent communication skills, with the ability to explain statistical concepts to both technical and non-technical audiences.
• Strong collaborative mindset and commitment to delivering high-quality work under tight timelines.
• Ability to thrive in a dynamic environment, manage ambiguity, and adapt to changing priorities.