Strategic Biostatistics Director — Hybrid Pharma Leadership

Asahi Kasei Therapeutics; Cary (NC); Presencial; USD 215 000 - 250 000; Tempo integral

Resumo da oferta

Asahi Kasei Therapeutics is seeking a Director of Biostatistics to lead statistical strategy across clinical development programs in a fast-paced biotech environment. You will oversee study design, analysis plans, and regulatory deliverables while guiding cross-functional teams.

Excellent communication and leadership are essential to influence decisions at the program level. Ideal candidates will have 10–15+ years of trial statistics experience, deep knowledge of ICH/FDA/EMA guidelines, and

Qualificações

• MSc or PhD in Biostatistics or Statistics.
• 10–15+ years of clinical trial statistics experience.
• Proven track record leading statistical activities across multiple studies.
• Strong knowledge of regulatory guidelines (ICH, FDA, EMA).
• 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.

Responsabilidades

• Provide program-level statistical leadership across one or more clinical development programs.
• Oversee study design and analysis plans; review SAPs and mock TLFs.
• Lead regulatory submissions and coordinate responses with health authorities.
• Manage CROs and external vendors to ensure quality and timelines.
• Translate complex statistics into actionable insights for stakeholders.

Conhecimentos

Leadership

Statistical oversight

Regulatory knowledge

SAS

R

Formação académica

MSc or PhD in Biostatistics/Statistics

Ferramentas

SAS

R

Descrição da oferta de emprego

Asahi Kasei Therapeutics is seeking a Director of Biostatistics to lead statistical strategy across clinical development programs in a fast-paced biotech environment. You will oversee study design, analysis plans, and regulatory deliverables while guiding cross-functional teams.

Excellent communication and leadership are essential to influence decisions at the program level. Ideal candidates will have 10–15+ years of trial statistics experience, deep knowledge of ICH/FDA/EMA guidelines, and