Senior Director, Biostatistics

About this role

About Beeline Medicines:

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

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…