Director/Senior Director, Biostatistics
About The Position
Lakefront Biotherapeutics is a global biotech company focused on building a differentiated immunology and inflammation pipeline. 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.
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 our colleagues lead healthy lives and to 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
