Principal Statistician Consultant-R&I (Respiratory & Immunology) REMOTE@EU/UK

Principal Biostatistician Consultant - Respiratory & Immunology (Remote)

ClinChoice is seeking a highly experienced Principal Biostatistician Consultant to join our client's Respiratory & Immunology team. This is a permanent, remote position based in Europe or the UK.

This role offers the unique advantage of working directly for a single sponsor while benefiting from the security and career development opportunities provided by a global Contract Research Organization (CRO).

About ClinChoice

ClinChoice is a global full-service CRO with over 28 years of experience in clinical development. We specialize in providing high-quality solutions to pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals across more than 20 countries, we are committed to accelerating the development of innovative drugs and devices. Our company culture emphasizes professional development, a supportive environment, and continuous training to ensure our employees are highly qualified and equipped to manage complex projects. We are an equal opportunity employer, celebrating diversity and inclusivity.

Key Responsibilities

• Lead protocol development, including study design, sample size calculation, randomization, and statistical analysis plans for assigned studies.
• Provide statistical oversight for studies, ensuring quality and consistency with project requirements.
• Ensure the completeness, accuracy, and consistency of data used for statistical analyses.
• Oversee the accuracy and timeliness of statistical analyses and their input into reports and decision-making processes.
• Validate statistical analyses and explore alternative strategies as needed.
• Demonstrate a deep 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 report text.
• Prepare the statistical methods section for reports, ensuring adherence to guidelines and project-wide consistency.
• Mentor peers on statistical methodology and provide training to less experienced statisticians.
• Manage the activities of statisticians across projects, coordinating assignments and reviewing work to ensure timely and high-quality project delivery.

Requirements

• Master's or PhD in Statistics, Biostatistics, or a related field.
• PhD with 2-4 years of relevant experience, or a Master's degree with 5-7 years of relevant experience.
• Strong proficiency in SAS programming.
• Experience in interpreting data for internal teams (clinical, statistical, etc.).
• Proven experience in a lead role, including programming in SAS and R, and experience providing CRO oversight.
• Experience with study readouts, including analysis of results from tables, listings, and figures.
• Specific experience within the Respiratory & Immunology therapeutic area, including Asthma studies.
• Excellent oral and written communication skills, with the ability to effectively communicate with internal teams and clients.
• Demonstrated understanding of statistics, the drug development process, and relevant FDA regulations.
• Experience in the pharmaceutical, CRO, or related industry, including clinical trials and interaction with Regulatory Agencies, particularly the FDA.

What We Offer

• The opportunity to work directly for a single sponsor while being employed by a global CRO.
• A permanent, remote position within Europe or the UK.
• A supportive and collaborative work environment.
• Opportunities for professional development and continuous training.
• The chance to contribute to the development of innovative treatments in the Respiratory & Immunology field.