This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Biostatistics based in the United States.
This senior leadership role sits at the intersection of clinical development strategy and advanced statistical science, driving the design and execution of high-impact clinical trials in immunology and inflammatory disease. You will provide strategic and hands-on biostatistical leadership across multiple clinical programs, shaping study design, statistical methodology, and regulatory strategy. The role involves close collaboration with cross-functional teams including clinical development, data management, regulatory affairs, and external vendors to ensure the integrity and success of clinical data. You will also play a key role in global health authority interactions, supporting submissions and responding to regulatory inquiries. This position requires both scientific depth and leadership capability, with responsibility for guiding teams and ensuring high-quality statistical deliverables. It is a highly visible role where your expertise directly influences clinical decision-making and the advancement of innovative therapies.
Accountabilities:
- Lead and oversee biostatistics, statistical programming, and data management activities at the program level, ensuring alignment across clinical development initiatives.
- Provide strategic statistical input into clinical trial design, protocol development, sample size determination, CRFs, and analysis interpretation.
- Author and review Statistical Analysis Plans (SAPs), ensuring high-quality specifications for derived datasets, tables, figures, and listings.
- Guide cross-functional teams on statistical methodology and collaborate closely with data management to ensure data quality and integrity.
- Support regulatory submissions and interactions with global health authorities by contributing to briefing documents, responses, and meetings.
- Oversee CROs and external vendors, ensuring timely, accurate, and compliant delivery of statistical outputs and study results.
- Conduct advanced statistical analyses, including ad hoc evaluations, and support interpretation for clinical study reports and safety updates.
- Develop and enhance biostatistical standards, processes, and innovative methodologies to improve study design and success probability.
Requirements:
- PhD in Biostatistics, Statistics, or a related field with 10–12+ years of experience in the pharmaceutical, biotech, or CRO industry.
- Strong expertise in statistical methodologies applied to clinical trials, with working knowledge of Bayesian methods preferred.
- Proven experience supporting regulatory submissions and engaging with global health authorities.
- Proficiency in statistical programming tools such as SAS and R, as well as clinical data standards including CDISC (SDTM, ADaM, CDASH).
- Experience working in matrixed, cross-functional environments with external vendors and global teams.
- Strong leadership skills with the ability to manage biometrics teams and influence scientific and clinical decision-making.
- Excellent communication, collaboration, and organizational abilities in complex, fast-paced environments.
- Strong understanding of clinical development processes within biotech or pharmaceutical settings.
Benefits:
- Competitive salary range of $275,000 to $290,000 annually, based on experience and location.
- Performance-based bonus and equity grant opportunities.
- Comprehensive health, dental, vision, and retirement benefits.
- Unlimited paid time off and two company-wide shutdown periods each year.
- Fully remote work environment with occasional in-person collaboration sessions.
- Strong emphasis on professional development and continuous learning opportunities.
- Opportunity to contribute to innovative therapies in immunology and inflammatory diseases.
- Inclusive, science-driven culture focused on advancing meaningful treatments for patients.