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.

• Demonstrated accountability, strong analytical thinking, and a data-driven approach to

problem-solving.

• Ability to work both independently and within a collaborative, matrixed team environment.

• Sense of urgency, initiative, and adaptability in a fast-moving, small-company setting.

• Excellent organizational, time management, and project leadership skills.

• High attention to detail and strong problem-solving capabilities.

• Willingness to learn, grow, and contribute to Company’s mission.

Working Behaviors (Core Expectations)

• Trust and Respect: Act with integrity, honesty, and openness to build strong, credible

relationships.

• Communication and Feedback: Share information clearly, listen actively, and engage in a

culture of constructive feedback.

• Accountability and Reliability: Take ownership for performance, be dependable, and support

others to achieve collective goals.

• Objectivity: Align on common objectives and use facts and data to reach fair, effective

decisions.

• Team Balance and Enablement: Contribute to balanced roles within the team, support

delegation, and help colleagues reach their full potential.