Senior Director, Biostatistics & Clinical Development

Asahi Kasei Bioprocess America, Inc.; Cary (NC); Hybrid; USD 215,000 - 250,000; Full time

Job summary

Asahi Kasei Bioprocess America, Inc. seeks a Director of Biostatistics to lead statistical activities across one or more clinical development programs. You will shape study designs, ensure consistency, and guide regulatory submissions in a dynamic biotech setting.

The role requires deep regulatory knowledge, strong communication, and ability to mentor junior statisticians while partnering with cross-functional leaders to drive development strategy.

Qualifications

• MSc or PhD in Biostatistics, Statistics.
• Significant experience (10-15+ years) in clinical trial statistics within biotech/pharma.
• Proven track record of leading statistical activities across multiple studies or programs.
• Strong working knowledge of regulatory guidelines (ICH, FDA, EMA) and statistical principles in drug development.
• Expertise in SAS; familiarity with R is beneficial.
• Excellent communication, leadership, and problem solving skills.
• Ability to balance hands on work with strategic program oversight in a fast paced biotech environment.

Responsibilities

• Provide program-level statistical leadership for one or more clinical development programs.
• Design scientifically sound and efficient clinical trials across phases.
• Oversee statistical sections of protocols, SAPs, and mock TLFs.
• Recommend statistical methodologies, estimands, and endpoints.
• Oversee CROs and external vendors and ensure quality and timelines.
• Contribute to data strategy, CDISC compliance, and cross-study data integration.
• Communicate results to clinical, regulatory, and senior leadership.

Skills

Leadership

Communication

Statistical expertise

Problem solving

Education

MSc or PhD in Biostatistics or Statistics

Tools

SAS

R

Job description

Asahi Kasei Bioprocess America, Inc. seeks a Director of Biostatistics to lead statistical activities across one or more clinical development programs. You will shape study designs, ensure consistency, and guide regulatory submissions in a dynamic biotech setting.

The role requires deep regulatory knowledge, strong communication, and ability to mentor junior statisticians while partnering with cross-functional leaders to drive development strategy.