We are seeking an experienced Principal Biostatistician Consultant to join a leading Respiratory & Immunology team supporting innovative clinical development programs, with a strong focus on Asthma studies. This is an exciting opportunity for a highly skilled biostatistician to play a strategic role in study design, statistical leadership, regulatory interactions, and cross-functional decision-making throughout the clinical development lifecycle.
Key Responsibilities
- Lead the statistical design and methodological strategy for clinical studies, including protocol development, sample size determination, randomization schemes, and statistical analysis plans (SAPs).
- Provide statistical leadership and oversight across assigned studies to ensure scientific rigor, quality, and compliance with project objectives.
- Ensure data used for statistical analyses are complete, accurate, and suitable for regulatory and clinical decision-making.
- Develop and review statistical analysis plans, study outputs, and key deliverables to ensure accuracy, consistency, and timely execution.
- Interpret study results and provide clear statistical insights to cross-functional stakeholders, including Clinical Development, Medical Affairs, Regulatory Affairs, and Project Teams.
- Evaluate and recommend alternative analytical approaches when appropriate to address complex scientific questions.
- Review and validate statistical tables, figures, listings (TFLs), clinical study reports, and statistical methods sections.
- Ensure consistency and quality of statistical reporting across projects while adhering to industry standards and regulatory requirements.
- Mentor and support statisticians by providing technical guidance, training, and expertise in statistical methodology.
- Coordinate and oversee statistical activities across multiple projects to ensure high-quality deliverables and successful timelines.
Qualifications
Required Education & Experience
- PhD in Statistics, Biostatistics, or a related quantitative field with 2–4 years of industry experience, or
- MS in Statistics, Biostatistics, or a related quantitative field with 5–7 years of industry experience.
Required Skills & Expertise
- Strong proficiency in SAS programming and statistical analysis.
- Experience developing and reviewing statistical analysis plans, study outputs, and clinical study reports.
- Ability to interpret and communicate complex statistical findings to both technical and non-technical stakeholders.
- Deep understanding of statistical methodologies, clinical trial design, and data analysis.
- Knowledge of drug development processes and FDA regulatory requirements.
- Excellent written and verbal communication skills.
Preferred Experience
- Direct experience within Respiratory & Immunology therapeutic areas, particularly Asthma clinical studies.
- Pharmaceutical, biotechnology, or CRO industry experience.
- Experience interacting with regulatory agencies, including the FDA.
Why Join?
- Work on impactful clinical development programs that help improve patient outcomes.
- Collaborate with experienced cross-functional teams and industry experts.
- Influence critical development and regulatory decisions through statistical leadership.
- Contribute to innovative Respiratory & Immunology research in a highly visible consulting role.
If you are passionate about applying advanced statistical expertise to drive successful clinical development programs, we’d love to hear from you.