Associate Director, Biostatistics Job Description:
Position Summary
The Associate Director, Biostatistics is responsible for partnering with clinical, regulatory, data
management and statistical programming teams to deliver robust statistical methodologies that
advance clinical program objectives and ensure compliance with industry standards. This
individual will contribute to the success of the team and organization by delivering on role-
specific responsibilities while upholding our core working behaviors of Trust and Respect,
Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and
Enablement.
Key Responsibilities
Serve as the lead statistician for clinical trials, contributing to efficient study design and
rigorous data analysis.
Provide high-quality statistical support across clinical programs, ensuring scientific
robustness and alignment with development goals.
Design and refine clinical trial methodologies; author study synopses and protocols.
Collaborate with data management on CRF design and database quality to ensure reliable
datasets.
Develop statistical analysis plans and ensure clear, transparent documentation.
Guide and mentor statistical programmers in creating SDTM/ADaM specifications, datasets,
and statistical outputs.
Review and approve statistical deliverables to ensure consistency, accuracy, and regulatory
readiness.
Interpret study results and contribute to clinical reports, presentations, publications, and
regulatory documentation.
Author statistical content for regulatory submissions and support interactions with global
health authorities.
Monitor timelines, deliverables, and support resource planning to keep programs on track.
Participate in vendor selection and provide oversight to ensure high-quality, timely
statistical outputs.
Contribute to the development and evolution of Biostatistics processes, standards, and best
practices at Company.
Communicate proactively, collaborate effectively, and maintain a solutions-oriented
approach in a dynamic, fast-paced environment.
Demonstrate ownership, accountability, and a commitment to delivering high-quality work.
Provide constructive feedback to support team development and shared success.
Skills and Qualifications
PhD in Biostatistics or related field with 5+ years of industry experience, or MS with 7+
years.
Experience in oncology drug development preferred.
Strong knowledge of FDA, EMA, and ICH guidelines, and a solid understanding of the end-to-
end drug development process.
Expertise in statistical methods for clinical trials, up to date knowledge of statistical
applications and the ability to communicate complex concepts clearly to diverse audiences.
Proficiency in SAS and R, and familiarity with CDISC SDTM and ADaM standards.
Experience contributing to NDAs, MAAs, or other global regulatory submissions.
Ability to collaborate effectively with CRO partners and manage outsourced statistical
activities.
Strong interpersonal and communication skills, with the ability to build trust and guide
cross-functional decision-making.