Principal Biostatistician Consultant - Respiratory & Immunology

Are you interested in working directly for a single sponsor while leveraging the security and career opportunities of a global Contract Research Organization (CRO)? Our team believes this offers the best of both worlds.

About the Role

ClinChoice is seeking a Principal Biostatistician Consultant to join one of our clients within their Respiratory & Immunology team. As a global full-service CRO, ClinChoice is committed to quality, professional development, and fostering a supportive culture. This client-facing role requires confident individuals who can work independently while building high-trust relationships with client counterparts.

Main Job Tasks and Responsibilities

• Lead protocol development, including study design, sample size calculation, randomization, and statistical analysis plans for assigned studies.
• Provide statistical oversight for studies, ensuring high quality and consistency with project requirements.
• Ensure data for statistical analyses are complete, accurate, and consistent.
• Oversee statistical analysis plans and ensure the accuracy and timeliness of statistical input into reports and decisions.
• Validate analyses and explore alternative analysis strategies as necessary.
• Demonstrate extensive understanding of statistical concepts and methodologies, identifying and correcting flaws in scientific reasoning and statistical interpretation.
• Ensure the accuracy and consistency of statistical tables, figures, and data listings, as well as the accuracy of report text and consistency between summary tables and source data.
• Author the statistical methods section for reports, identifying and correcting common interpretation flaws, presentation inconsistencies, and ensuring adherence to report guidelines and project-wide consistency.
• Mentor peers on statistical methodology and provide training to less experienced statisticians.
• Manage the activities of statisticians across projects by coordinating assignments and reviewing work to ensure timely, high-quality project delivery.

Education and Experience

• MS or PhD in Statistics, Biostatistics, or a related field.
• PhD with 2-4 years of relevant experience.
• MS with 5-7 years of relevant experience.
• Strong SAS programming skills.
• Experience interpreting data for internal teams (clinical, statistics, etc.).
• Requires lead experience with SAS and R programming, and experience providing CRO oversight.
• Experience working on study readouts, including analysis results from tables, listings, and figures.
• Required: Respiratory & Immunology Therapeutic Area (TA) experience, specifically with Asthma studies.
• Excellent oral and written communication skills, with the ability to communicate effectively internally and with clients.
• Demonstrated understanding and insight in statistics, the drug development process, and relevant FDA regulations.
• Experience in the pharmaceutical, CRO, or related industry with clinical trials, including interaction with Regulatory Agencies, particularly the FDA.

The Application Process

Upon CV submission, you will receive an acknowledgement. If your qualifications match our requirements, you will be invited for an initial phone interview. Due to the volume of applications, we regret that we cannot reply individually to every applicant if you are not successful.

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of high-quality delivery, we employ over 4,000 professionals across more than 20 countries in the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission—to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices—drives our culture. Our employees are our most valuable asset, forming the core of all ClinChoice activities. We prioritize close management and training to develop and maintain highly qualified personnel, ensuring competence and expertise. Continuous training equips our team with the tools to manage internal and client processes consistently. Our commitment to these values is reflected in our below-industry-average turnover rates.

Equal Opportunity Employer

ClinChoice is an equal opportunity employer committed to attracting, developing, and promoting talent through diversity and inclusivity. We celebrate the diverse backgrounds of our employees, recognizing that gender, race, beliefs, and ethnicities are our strength.

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