Senior​/Principal Biostatistician FSP

About the Role

Who Are You? An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic. You 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.

Working fully embedded within a global pharmaceutical client, you will be a Senior Biostatistician dedicated to their innovation projects. You will perform ad‑hoc or exploratory analyses to support submissions or health authority questions, handling medium complexity trials from design to archival. Regulatory experience is a bonus.

• Providing statistical support to clinical studies
• Participating in the development of study protocols, including 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 and interpreting statistical results
• Preparing clinical study reports, including integrated summaries for submissions
• Utilizing strong communication skills to present and explain methodology and the consequences of decisions
• Understanding and following FDA regulations affecting reporting of clinical trial data, good clinical practice, and guidelines for electronic submissions
• Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participating in the development of CRFs, edit check specifications, and data validation plans
• Providing review and/or authoring of data transfer specifications for external vendor data
• Collaborating with internal and external functions (e.g., CROs, software vendors, clinical development partners) to ensure meeting project timelines and goals
• Providing review and/or authoring of SOPs and work instructions related to statistical programming practices

• Master’s degree in statistics or a related discipline;
  Ph.D. 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, SAP, and preparing clinical study reports including integrated summaries for submissions
• Good SAS programming skills for QCing critical outputs, efficacy/safety tables, and working closely with programmers; R programming knowledge is a plus
• Solid understanding and implementation of CDISC requirements for regulatory submissions
• Adept in ADaM specifications generation and data set QC
• Ability to build strong external and internal relationships and motivate a regional or global team
• Effective communication: able to explain methodology and decisions in lay terms

Mid‑Senior level

Full‑time

Research, Analyst, and Information Technology

Pharmaceutical Manufacturing