Director/Senior Director, Biostatistics
About The Position
Lakefront Biotherapeutics is a global biotech company focused on developing a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. The company is building a team where science, execution, and accountability matter, operating with small, empowered teams that work hands-on across development stages. They are looking for individuals who want to contribute directly, are motivated by solving real problems, enjoy collaborating across disciplines, and take ownership from idea to impact. Lakefront aims to advance programs with strong biological rationale, clear clinical proof of concept, and large commercial opportunities. The role of Director or Senior Director of Biostatistics is a highly visible, cross-functional position serving as the statistical lead across the autoimmune clinical pipeline. This role involves owning the statistical strategy from design through data analysis, interpretation, and regulatory submission. The ideal candidate will have deep therapeutic area knowledge, strong development experience, strategic instincts, and the scientific judgment to influence program and portfolio decisions. The Biostatistics function will be defined and built by the successful candidate as the portfolio expands.
Requirements
- Ph.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)
- 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
- 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
Nice To Haves
- Experience with adaptive trial designs, Bayesian methods, or other innovative design frameworks is a strong plus
- Experience in immunology, rheumatology, gastroenterology, or other autoimmune/inflammatory disease areas preferred
Responsibilities
- 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
Benefits
- Competitive compensation and benefits package
- Performance-based annual cash bonus
- New hire equity grant
- Eligibility for annual equity awards
- Comprehensive and generous benefits and programs to help colleagues lead healthy lives and support important moments in life
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
