Job Description

We are seeking a talented Clinical Biostatistician to join our team and play a key role in driving the statistical aspects of clinical studies, assay development, and epidemiological and healthcare economic modeling using real-world data. In this role, you will collaborate with interdisciplinary teams to design studies, develop statistical analysis plans, provide statistical support for assay development, and conduct epidemiological modeling to support evidence-based decision-making.

Responsibilities:

Clinical Study Design:

• Collaborate with clinical and research teams to support clinical study and trial design, including sample size determination, randomization and blinding procedures, and other statistical considerations
• Provide expertise in statistical methods and study design to ensure robustness, reliability, and ethical conduct of clinical research

Statistical Analysis Plans (SAP):

• Develop and write detailed statistical analysis plans (SAP) outlining the analysis methods, endpoints, and statistical techniques to be used in clinical studies
• Ensure SAPs are aligned with study objectives, regulatory requirements, and industry standards

Design of Experiment (DOE) Statistical Support for Assay Development:

• Provide statistical guidance and support for assay development projects, including experimental design, data analysis, and interpretation
• Apply Design of Experiment (DOE) principles to optimize assay performance, sensitivity, and specificity

Epidemiological and Healthcare Economic Modeling with Real World Data:

• Utilize real-world data sources (e.g., electronic health records, screening data) to conduct epidemiological studies and modeling
• Conduct robust healthcare economic analyses to characterize the impact of early detection of cancer in large-scale screening programs
• Develop and implement statistical models to analyze healthcare outcomes, disease trends, and treatment effectiveness
• Collaborate with epidemiologists and public health experts to translate findings into actionable insights

Statistical Analysis and Interpretation:

• Perform statistical analyses of clinical and epidemiological data using appropriate statistical software (e.g., R)
• Interpret statistical results, prepare summary reports, and communicate findings to stakeholders including researchers, clinicians, and regulatory agencies

Quality Control and Assurance:

• Ensure data integrity, accuracy, and completeness through rigorous quality control procedures
• Implement and adhere to regulatory guidelines and industry standards for statistical analysis and reporting
• Participate in an internal Data Safety and Monitoring Committee

Qualifications:

• Master’s or Ph.D. in Biostatistics, Statistics, Epidemiology, or a related field
• Strong statistical background with expertise in study design, data analysis, and statistical modeling
• Experience in clinical research, preferably in the pharmaceutical, biotechnology, or healthcare industry
• Proficiency in statistical software packages such as SAS or R
• Knowledge of regulatory requirements (e.g., FDA, ICH) and guidelines for clinical trials and epidemiological studies
• Excellent written and verbal communication skills, with the ability to convey complex statistical concepts to diverse audiences
• Strong problem-solving abilities and attention to detail

Preferred Qualifications:

• Experience in the preparation of data packages for FDA submission
• Experience with real-world data analysis and epidemiological modeling techniques, including applications in healthcare economics
• Familiarity with machine learning methods and their applications in healthcare analytics
• Knowledge of Bayesian statistics and its applications in clinical research
• Prior experience in designing experiments and optimizing assays using statistical methods
• Understanding of healthcare informatics and electronic health records (EHR) data
• Certification in Clinical Trials or Epidemiology (e.g., CCRA, CPH) is a plus