Principal Statistician Consultant – R&I, Respiratory & Immunology

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee the creation of protocols, which includes study design, sample size calculations, randomization, and the development of statistical analysis plans for designated studies.

• Provide statistical guidance to studies, ensuring quality and compliance with project specifications.

• Ensure that data used for statistical analyses is complete, accurate, and consistent.

• Accountable for statistical analysis plans and the precision and timeliness of statistical contributions to reports or decisions.

• Guarantee the validity of analyses and investigate alternative analytical approaches as required.

• Exhibit a profound understanding of statistical principles and methodologies, identifying and rectifying errors in scientific reasoning and statistical interpretation.

• Ensure the accuracy and consistency of statistical tables, figures, and data listings, as well as the correctness of report text, maintaining alignment between summary tables in reports and their corresponding source tables and listings.

• Responsible for the statistical methods section of reports, identifying and addressing common misinterpretations of results, inconsistencies in presentation or inference, and compliance with report guidelines, while ensuring project-wide consistency.

• Effectively mentor colleagues on statistical methodologies and provide suitable training to junior statisticians.

• Oversee the activities of statisticians across various projects by coordinating assignments and reviewing their work to ensure timely delivery with high quality.

⛳️ Requirements

• MS or PhD in Statistics, Biostatistics, or a related discipline. A PhD with 2-4 years of experience or an MS with 5-7 years of experience is required.

• Proficient in SAS.

• Ability to interpret data for internal teams, including clinical and statistical groups.

• Must have leadership experience with programming skills in SAS and R, along with experience in providing oversight to CROs.

• Experience in study readouts, specifically analyzing results from tables, listings, and figures.

• Experience in Respiratory & Immunology therapeutic areas, particularly with asthma studies.

• Strong verbal and written communication skills, with the capability to effectively engage with internal teams and clients.

• Proven understanding and insight into statistics, the drug development process, and pertinent FDA regulations.

• Experience in the pharmaceutical, CRO, or related industries, specifically with clinical trials and interaction with regulatory agencies, especially the FDA.

🏝️ Benefits

• Health insurance

• Professional development opportunities