Biostatistics Associate

Job purpose

To design, plan, and execute biostatistical components of clinical studies by applying appropriate statistical methodologies to protocol development, statistical analysis plans, and clinical study reporting. The role is responsible for producing and reviewing statistical analyses, TFL shells, and reports, ensuring accurate interpretation and presentation of clinical data. The position supports the development, review, and validation of statistical outputs and datasets, contributes to study documentation, and communicates statistical results effectively to stakeholders using strong analytical, computing, and professional communication skills.

Duties and responsibilities
Design, plan, and execute biostatistical components of clinical studies in accordance with study protocols and regulatory standards.
Develop, review, and contribute to Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells and reporting specifications.
Perform statistical analyses for clinical studies using appropriate and validated statistical methodologies, independently for simple studies or under guidance for complex studies.
Prepare, review, and validate statistical outputs, including tables, figures, listings, and shell displays.
Interpret and document statistical results to support clinical study conclusions and decision-making.
Contribute to the preparation and review of statistical sections of clinical study protocols, reports, and other regulatory documents.
Review tabulation datasets, derived datasets, and TFLs to ensure accuracy, consistency, and compliance with analysis specifications.
Provide statistical expertise to support cross-functional teams and ensure clarity and accuracy of reported results.
Maintain clear and effective written and verbal communication of statistical findings in English.
Utilize advanced computer and analytical tools to support data analysis, reporting, and project documentation.

Qualifications and Experience
Master’s degree or higher in Biostatistics, Statistics, Mathematics, or a related discipline.
Proven 5 years’ experience in statistical analysis and reporting of clinical studies.
Experience developing Statistical Analysis Plans (SAPs), including TFL shells.
Ability to perform and review statistical analyses, outputs, and derived datasets.
Strong analytical skills with accurate interpretation of clinical data.
Excellent written and verbal communication skills in English.
Proficiency in MS Word, Excel, PowerPoint, and project management tools.
Skills & Competencies
Proficiency in developing Statistical Analysis Plans (SAPs), TFL shells, and reporting specifications.
Expertise in reviewing statistical outputs, including tables, figures, listings, and derived datasets.
High analytical and problem-solving skills with strong attention to detail.
Effective written and verbal communication skills in the English language.
Strong collaboration skills to work effectively with cross-functional teams.
Advanced computer skills, including MS Word, Excel, PowerPoint, and project management software.
Ability to work independently on routine analyses and under guidance for complex studies.

Working conditions
This position operates in an office setting, in person.
Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Direct reports
N/A