Senior Biostatistics Director

Job Summary:

The Senior Director, Biostatistics is a senior scientific and functional leader responsible for providing strategic statistical leadership for the organization's clinical development portfolio and contributing to the build-out of the broader Biometrics function. This role serves as the organization's senior hands-on biostatistics expert — owning statistical strategy and methodology for assigned programs, leading the design, analysis and reporting of clinical trials, and serving as a key statistical voice in regulatory interactions and submissions. The Senior Director operates with a high degree of scientific independence, plays a critical role in shaping trial design and quantitative development strategy, and contributes meaningfully to the development of the Biometrics team and its functional capabilities. Operating in a clinical-stage I&I biotech, this individual brings deep statistical expertise across early and late-phase development, a strong track record in regulatory submissions, and the leadership presence to represent Biostatistics as a strategic partner across the organization.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Provide senior statistical leadership for assigned clinical programs — owning statistical strategy, trial design, and methodology across all phases of development (Phase I–III) and ensuring statistical approaches are scientifically rigorous, regulatorily defensible, and aligned with program objectives.
• Lead the development and review of trial designs, statistical analysis plans (SAPs), randomization strategies, and statistical sections of clinical protocols — applying advanced statistical methodology and regulatory knowledge to optimize program design and efficiency.
• Serve as the organization's senior statistical expert in regulatory interactions — contributing to the preparation of statistical sections for INDs, NDA/BLA submissions, and global filings, and representing Biostatistics at FDA, EMA, and other health authority meetings.
• Provide statistical consulting and methodological guidance across the organization — including to Clinical Development, Translational Medicine, Medical Affairs, and Clinical Pharmacology — ensuring quantitative rigor is embedded in all aspects of program development.
• Oversee the quality and regulatory compliance of statistical deliverables — including TLFs, analysis datasets (CDISC SDTM/ADaM), and integrated submission packages — ensuring all outputs meet the highest standards of statistical accuracy and regulatory acceptability.
• Contribute to the build-out and continuous improvement of the Biostatistics function — developing statistical processes, standards, and best practices, and supporting the recruitment and development of statistical talent within the Biometrics organization.
• Manage and provide scientific oversight of CRO statistical partners — establishing governance frameworks, reviewing statistical deliverables, and ensuring external statistical teams meet organizational quality and regulatory standards.
• Contribute to business development and in-licensing evaluations through statistical due diligence — assessing the design quality, statistical integrity, and regulatory acceptability of external program data packages.
• Represent the organization at industry working groups, scientific conferences, and regulatory workshops on biostatistics and quantitative science topics.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: PhD in Biostatistics, Statistics, or a closely related quantitative discipline required. Advanced training or publications in clinical trial methodology, advanced statistical modeling or regulatory statistics is a strong plus.
• Minimum of 12 years of biostatistics experience in the pharmaceutical, biotech, or CRO industry, with demonstrated depth in clinical development strategy, clinical trial design and analysis, and regulatory submission experience (IND, NDA/BLA, or MAA).
• Experience in immunology, inflammation, or a related therapeutic area preferred.
• Expert-level statistical expertise in clinical trial design, analysis methodology, and regulatory strategy — including adaptive designs, estimands, missing data handling, advanced modeling of complex, data,endpoint development, and real-world evidence applicable to I&I development programs.
• Deep proficiency in statistical programming languages (SAS, or R) and clinical data standards (CDISC SDTM, ADaM, Define.xml) — with strong understanding of CDISC implementation and its application to regulatory submission packages.
• Extensive experience with FDA, EMA, and ICH regulatory guidance relevant to biostatistics — including E9(R1) estimands framework, adaptive design guidance, and the preparation of statistical sections for IND, NDA/BLA, and MAA submissions.
• Experience with CRO statistical oversight and governance — including statistical deliverable review, CRO quality management, and the establishment of biostatistics standards within a virtual or outsourced development model.
• Senior scientific leader with organizational influence — serves as the statistical authority for the development portfolio and contributes meaningfully to Biometrics function-building, process development, and talent strategy.
• Strategic cross-functional partner — engages Clinical Development, Regulatory, Clinical Pharmacology, and executive leadership as a trusted quantitative expert whose input shapes program design and regulatory strategy
• Skilled in preparing and presenting statistical sections of regulatory submissions, briefing documents, and scientific publications to the highest standards of statistical accuracy and regulatory acceptability.
• Collaborative and proactive cross-functional communicator — positions Biostatistics as a strategic scientific partner across the organization, not simply a delivery function.