Director, Biostatistics

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Biostatistics based in United States. This is a senior biostatistics leadership role supporting the design, analysis, interpretation, and reporting of clinical development programs. You will contribute across multiple studies, providing statistical expertise from protocol development through regulatory submissions and final reporting. The role has a strong focus on oncology clinical trials, including complex Phase 3 programs and global regulatory requirements. You will oversee statistical programming and deliverables while ensuring the quality, integrity, and compliance of clinical analyses. Working cross-functionally, you will collaborate with clinical, data management, regulatory, and other development teams to translate data into meaningful evidence. You will also provide oversight of CRO statistical deliverables and contribute to business-critical and regulatory commitments. This opportunity is well suited to an experienced biostatistician who combines technical depth, independent judgment, and a strong commitment to scientific excellence.

You will lead and coordinate statistical activities across clinical studies, ensuring high-quality analyses and clear communication of evidence throughout the development lifecycle. Lead statistical activities supporting the design, execution, analysis, interpretation, and reporting of clinical trials. Provide statistical expertise for business-critical initiatives and regulatory commitments. Contribute to clinical program plans and represent the Biostatistics function on cross-functional and intra-departmental teams and working groups. Prepare or review clinical study protocols, case report forms, statistical analysis plans, and table shells. Create, review, or validate SAS programs supporting data management activities, compliant analysis datasets, and statistical analyses. Oversee statistical programming and deliverables to support the quality assurance and control of clinical analyses. Prepare statistical sections of clinical study reports and communicate study results through presentations and other formal materials. Write statistical reports, analyses, and scientific memos with minimal supervision. Validate complex datasets, analyses, and summary tables to ensure accuracy and reliability. Provide oversight and guidance to CROs on statistical deliverables, timelines, and quality expectations. Apply appropriate statistical methodology and regulatory guidance throughout clinical development activities. Maintain organized and confidential project documentation and materials. Identify opportunities to improve statistical processes, efficiency, quality, and innovation. Take on additional responsibilities as needed to support clinical development objectives. Requirements: The ideal candidate brings extensive clinical trial biostatistics experience, strong oncology expertise, and the ability to independently lead complex statistical activities in a pharmaceutical or biotechnology environment. Master's degree in Statistics, Biostatistics, or a closely related quantitative field required; PhD preferred. 7+ years of experience supporting clinical trials and drug development programs. At least 2 years of experience in oncology clinical trials. Strong experience with solid tumor oncology is preferred. Experience supporting global NDA/BLA submissions is highly valued. Experience designing, executing, and reporting Phase 3 oncology clinical trials as a lead statistician is preferred. Strong knowledge of statistical programming and analysis software, particularly SAS and R. Familiarity with S-PLUS, SQL, or other statistical analysis and reporting applications is a plus. Strong understanding of statistical methodology and regulatory guidance as applied to pharmaceutical clinical development. Excellent written and verbal communication skills, with the ability to clearly articulate complex statistical concepts. Strong problem-solving, analytical, planning, and organizational skills. Ability to independently prioritize multiple projects and meet demanding delivery timelines. Strong judgment and decision-making skills, with the ability to work effectively with limited supervision. High sense of urgency and commitment to quality and excellence. Continuous improvement mindset, with an interest in driving innovation and operational efficiency. Flexible and adaptable approach to working in a dynamic clinical development environment. Positive, approachable, and professional attitude with strong cross-functional collaboration skills. Benefits: Base salary range of $195,000–$215,000 USD , depending on experience and qualifications. Annual performance incentive bonus eligibility. New-hire equity package. Medical insurance. Dental insurance. Vision insurance. 401(k) company match. Paid time off. Paid holidays. Competitive total compensation package. Opportunity to contribute to innovative oncology clinical development programs and meaningful advances in targeted therapies.

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