Senior Manager, Biostatistics

Job Summary

The Senior Manager, Biostatistics provides technical leadership and biostatistical expertise in the design, execution, analysis, and interpretation of clinical trial data. This role supports program-level statistical strategies, oversees study-level analyses, and contributes to regulatory submissions and departmental process improvements. The position plays a critical role in ensuring statistical integrity and compliance across clinical development programs while collaborating with cross-functional teams to support decision-making and data-driven strategies.

Key Responsibilities

• Design, evaluate, and interpret clinical trial data, providing statistical input throughout study planning and execution.

• Draft and review statistical analysis plans (SAPs), tables, listings, and figure (TFL) specifications.

• Review case report forms (CRFs) and other key study documents to ensure statistical alignment.

• Manage and oversee CRO statistical activities, including validation of outputs and deliverables.

• Generate and review study randomization files and contribute to protocol and IDMC charter development.

• Present and interpret statistical results, author statistical sections for clinical study reports (CSRs) and publications.

• Support regulatory responses, submissions, and reimbursement-related data packages.

• Provide statistical input to inform clinical development strategies, interim analyses, and innovative study designs.

• Contribute to advanced statistical research and methodological innovation within the department.

• Participate in establishing and maintaining departmental standards, procedures, and training.

• Collaborate cross-functionally to ensure data integrity and consistency across programs.

Qualifications

• PhD in Biostatistics or Statistics with 5+ years of relevant pharmaceutical experience, or Masters degree with 7+ years of experience.

• Strong foundation in biostatistical methods for clinical trials and related study designs.

• Proven experience in authoring SAPs, TFL specifications, and validating statistical outputs.

• Knowledge of CDISC standards (SDTM, ADaM) and relevant controlled terminologies.

• Familiarity with regulatory guidance documents (ICH, FDA, EMA).

• Proficient in SAS and experienced with R or Python.

• Excellent organization, problem-solving, and multitasking skills.

• Strong communication and collaboration skills in a cross-functional environment.

• Experience with longitudinal data analysis, adaptive design, and advanced methods involving real-world data, machine learning, or AI is preferred.