Title: Clinical Data Analyst Statistician
Note: This role goes beyond routine data analysis. The ideal candidate must possess deep expertise in clinical trial design, statistical methodologies, regulatory frameworks, and the practical implementation of statistical strategies within the pharmaceutical industry.
Project Overview:
The role involves the development and management of the comprehensive statistical approach for a Phase III clinical trial evaluating a new therapeutic indication for Lebrikizumab. The successful candidate will be responsible for ensuring the statistical integrity and scientific rigor of the trial by aligning design, analysis, and reporting with industry best practices and regulatory requirements.
Key Responsibilities:
* Lead and contribute to the creation of statistical plans and strategies, ensuring alignment with clinical objectives and regulatory standards.
* Provide expertise in dossier preparation, particularly across the full lifecycle of clinical studies (F1–F4), including study design, execution, analysis, and reporting.
* Apply advanced knowledge in clinical trial design, including defining protocols, developing statistical analysis plans (SAPs), creating shell tables, and determining estimands for study endpoints.
* Utilize statistical techniques to address complexities such as missing data, multiplicity adjustments, and other frequentist methods commonly applied in clinical trials.
* Perform simulations to support sample size estimation, power calculations, and scenario planning, ensuring robustness of statistical conclusions.
* Offer guidance on Bayesian methodologies as an advanced approach for data interpretation and adaptive trial designs.
* Collaborate with cross-functional teams, providing statistical consultation, training, and leadership to ensure data quality and consistency across all phases of the trial.
* Ensure adherence to ICH guidelines and other regulatory frameworks such as FDA and EMA requirements throughout the study lifecycle.
Qualifications:
* At least 10 years of experience working as a statistician within the pharmaceutical or biotech industry, with demonstrable contributions to late-phase clinical trials.
* Prior experience with dossier submissions and regulatory documents across F1–F4 studies.
* Strong background in defining and implementing clinical protocols, statistical analysis plans, and reporting frameworks.
* Proficiency in handling complex datasets, including missing data techniques, multiplicity corrections, and advanced modeling.
* Experience with simulations and scenario-based statistical planning.
* Knowledge of ICH guidelines and familiarity with global regulatory expectations.
* Experience in coordinating statistical teams and collaborating with clinical, data management, and regulatory departments.
* Exposure to Bayesian statistical approaches is highly desirable.
Work Arrangement:
This is a hybrid, part-time position offering flexibility, designed for candidates who can bring strategic statistical expertise to a high-impact clinical trial while working collaboratively across teams.