Associate Director, Biostatistics

Summary

We are seeking an Associate Director, Biostatistics provides strategic and operational statistical leadership for one or more clinical development programs, serving as the primary statistical contact and principal statistical representative on cross-functional study and program teams. You will lead statistical input into protocols, analysis plans, and regulatory submissions, while overseeing CRO/vendor deliverables and ensuring inspection-ready, compliant statistical work across assigned studies. The ideal candidate brings deep late-stage clinical trial statistics expertise, strong regulatory and CDISC knowledge, and the leadership capability to mentor statisticians and represent Biostatistics in cross-functional and health-authority settings.

Responsibilities

• Provide statistical leadership for the design, conduct, analysis, interpretation, and reporting of assigned clinical studies, including endpoints, estimands, sample size, randomization, interim analyses, multiplicity, and missing-data strategies

• Serve as the principal statistical representative on cross-functional study/program teams, communicating risks, assumptions, and recommendations clearly to stakeholders

• Author or oversee statistical analysis plans, TLF shells, and study-level statistical documents, and review CRFs, database specs, and SDTM/ADaM datasets for analysis fitness

• Oversee statistical analyses and independent quality control of programs, datasets, and outputs, interpreting efficacy/safety results in clinical context for CSRs, publications, and decision materials

• Contribute statistical content to health-authority briefing documents, regulatory submissions, and responses to regulatory questions, and support FDA/EMA meeting preparation as assigned

• Lead or support CRO/vendor selection, contracting, and oversight, including scope, budgets, timelines, quality expectations, and performance resolution

• Provide technical guidance, coaching, and review to statisticians, programmers, and contractors, fostering a culture of scientific integrity and collaboration

• Represent Biostatistics in governance forums, vendor meetings, audits, and inspections as assigned

Qualifications & Experience

• PhD in Biostatistics, Statistics, or a closely related quantitative discipline with 9+ years of relevant pharma/biotech/CRO experience (or Master's with 12+ years)

• Demonstrated experience as lead statistician for Phase 1–3 clinical studies; late-stage or registration-directed development experience strongly preferred

• Strong knowledge of clinical trial design, estimands, statistical methods, multiplicity, sensitivity analyses, and global regulatory guidance (ICH E6, E9, E9(R1), FDA/EMA expectations)

• Working knowledge of CDISC standards (SDTM, ADaM), proficiency in SAS, and familiarity with R or other validated statistical computing environments

• Experience directing CRO statisticians/programmers and overseeing budgets, timelines, and quality/compliance of outsourced statistical work

• Strong communication and scientific judgment, with preferred experience supporting health-authority interactions and mentoring statisticians or leading matrix teams

Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.