Director/Senior Director, Biostatistics

The Role

We are seeking a Director or Senior Director of Biostatistics to serve as the statistical lead across our autoimmune clinical pipeline. This is a highly visible, cross-functional role in which you will own the statistical strategy for our clinical programs — from designing statistical strategy through data analysis, interpretation of results, and regulatory submission. You will work hand-in-hand with other functions, and will have the opportunity to define and build the Biostatistics function as our portfolio expands. The ideal candidate brings deep therapeutic area knowledge, strong development experience and strategic instincts, and the scientific judgment to help shape go/no-go decisions at the program and portfolio levels.

What You'll Do

• Serve as the biostatistics lead on one or more development programs, building the statistical framework needed to assess evidence gathered over the development lifecycle
• Analyze data from ongoing and completed clinical trials, including CSRs, patient-level datasets, and interim readouts, to identify trends and signals in safety, efficacy, and patient subgroups to support development decisions
• Contribute to the design of clinical studies (e.g. adaptive, seamless Phase 2/3, and dose-finding designs) to support evidence generation and development objectives
• Collaborate with clinical, regulatory, and translational teams to define primary and secondary endpoints, estimands, and success criteria aligned with regulatory expectations and clinical meaningfulness
• Review and interpret statistical outputs, contributing to CSRs, regulatory submissions (IND, NDA/BLA), and briefing documents for health authority interactions
• Support interactions with FDA, EMA, and other health authorities on statistical methodology and trial design questions
• Oversee CRO biostatistics and/or biometrics vendors and contract statisticians, ensuring scientific rigor and timeline adherence
• Stay current with evolving regulatory guidance and methodological advances relevant to immunology and inflammation clinical development
• Help build a high-functioning Biostatistics capability as the organization grows

What You Bring

• D. in Biostatistics, Statistics, or a closely related quantitative discipline; M.S. considered with substantial industry experience
• 10+ years (Director) or 15+ years (Sr. Director) of industry experience in clinical biostatistics, with direct responsibility for Phase 1 through Phase 3 programs in a pharmaceutical or biotech setting
• Deep knowledge of ICH guidelines (E8, E9, E9(R1), E10, E17) and FDA/EMA statistical guidance relevant to drug development
• Hands-on expertise in statistical programming environments (SAS required; R strongly preferred) and CDISC data standards (SDTM, ADaM, TLF production)
• Experience with adaptive trial designs, Bayesian methods, or other innovative design frameworks is a strong plus
• Proven ability to author and defend statistical sections of regulatory submissions, including SAPs, CSRs, and integrated summaries in written, virtual, and in-person regulatory interactions
• Experience in immunology, rheumatology, gastroenterology, or other autoimmune/inflammatory disease areas preferred
• Strong scientific communication skills — able to present complex statistical concepts clearly and coherently to stakeholders at all levels of the company
• Comfortable operating in a lean biotech environment with CRO-dependent execution and cross-functional accountability

What We Offer

• Base compensation for this position ranges from $230,000 - 300,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location.
• The company reserves the right to modify base salary ranges at any time.
• This position is eligible for participation in Lakefront Biotherapeutics’ performance bonus plan.
• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.