Role Summary

The Senior Biostatistician provides, and may lead, statistical contributions to a clinical development program. The Principal Biostatistician implements statistical strategies for clinical trials and regulatory submissions within the program and is accountable for all statistical deliverables.

Main Responsibilities and Accountabilities

• Contribute to the statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.

• Provide statistical support for data collection, analysis, reporting, and submission preparation.

• Ensure the timely completion and quality of the Statistical Analysis Plan (SAP).

• Support Biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA).

• Interpret analysis results and ensure accuracy and clarity of reporting.

• Manage outsourced statistical activities or collaborate with internal statistical programmers; ensure the timeliness and quality of CRO/FSP deliverables and conduct quality reviews.

• Oversee preparation of Tables, Figures, and Listings (TFLs) and CDISC packages for study reports and regulatory submissions.

• Support continuous improvement initiatives and contribute to standards related to infrastructure, processes, and scientific consulting.

Job Qualifications and Experience Requirements

Education

• PhD or MS in Biostatistics, Statistics, or a related field

Experience

• PhD with at least 3 years of experience in drug development, or

• MS with at least 6 years of experience in drug development

Competencies

• Advanced knowledge of statistical methodologies in clinical development

• Ability to collaborate effectively and provide leadership in a matrix environment

• Strong interpersonal and communication skills (written and verbal in English)

• Proficiency in SAS and/or R

• Familiarity with relevant regulatory guidance documents

Technical Expertise

• CDISC standards, statistical programming, and/or data standards

• Biostatistics and Statistical Programming Operations