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About 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.

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

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)
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

Skills

SAS
R
CDISC data standards
SDTM
ADaM
TLF production
adaptive trial designs
Bayesian methods
scientific communication

Location

Belgium
Chicago
San Francisco

Work Type

Full-time

Experience Level

Director
Senior Director

Education Level

Ph.D. in Biostatistics
Ph.D. in Statistics
Ph.D. in a closely related quantitative discipline
M.S. with substantial industry experience

Salary/Compensations

$230,000 - $300,000

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

About the Company

Lakefront Biotherapeutics is a global biotech focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need.
Our pipeline is anchored by T‑cell engager programs, led by a potential first‑in‑class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease.
We are building a company where science, execution, and accountability matter.
We operate with small, empowered teams that work hands‑on across development stages to move programs forward efficiently and thoughtfully.
We are looking for people who want to contribute directly, who are motivated by solving real problems, collaborating across disciplines, and taking ownership from idea to impact.
At Lakefront, every role plays a part in shaping the future of medicines that have the potential to make a meaningful difference for patients.
If you are driven to improve the lives of patients, energized by execution, and excited to help build a growing company with a strong balance sheet, we look forward to meeting you.

Equal Opportunity

Lakefront Biotherapeutics is dedicated to ensuring equal employment opportunities.
Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements.
We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.