Director, Biostatistics

Altimmune•Morristown, NJ

2d•Hybrid

About The Position

Altimmune is a late clinical-stage biopharmaceutical company focused on developing therapies for serious liver diseases. Their primary candidate, pemvidutide, is a dual-action therapy targeting glucagon and GLP-1 receptors, currently in development for MASH, AUD, and ALD. This Director, Biostatistics role is a high-visibility, high-impact position crucial for Altimmune's growth. The role reports to the Senior Director, Biostatistics and will provide statistical leadership and serve as the lead statistician for one or more clinical development programs. The individual will collaborate with cross-functional teams including clinicians, clinical scientists, statistical programmers, data managers, regulatory, and clinical operations professionals. Responsibilities include planning, conducting, and analyzing clinical studies of all phases, ensuring the quality of statistical design, programming, analysis, and data reporting. The role also involves representing the company in interactions with external statistical and data management service providers and participating in discussions with regulatory agencies.

Requirements

PhD in Statistics, Biostatistics, or related field with 7+ years of clinical trial statistics experience in biotech/pharma; or MS with 10+ years of equivalent industry experience.
Strong knowledge of statistical methods relevant to clinical trials, including longitudinal data, survival analysis, and Bayesian approaches.
Experience with regulatory interactions and submissions, including familiarity with FDA and/or EMA expectations for statistical evidence.
Proficiency in SAS and/or R; extensive experience with CDISC standards (SDTM, ADaM).
Excellent communication and leadership skills with the ability to translate complex statistical concepts for non-statistical audiences, including clinicians, regulators, and senior leadership.
A self-directed individual who can excel both independently and as a team player in a fast-paced, entrepreneurial environment.
History of successful participation within an interdisciplinary team.

Nice To Haves

Experience serving as the lead statistician for Phase 3 clinical trials and supporting NDA and/or BLA regulatory submissions is highly desirable.
Prior experience in metabolic diseases, liver disease, or related indications (e.g., NASH/MASH, obesity) is highly desirable.
Experience with external control arms or synthetic cohort matching.
Familiarity with non-invasive biomarkers and imaging endpoints.

Responsibilities

Serve as the lead statistician for one or more clinical development programs, providing statistic and operational leadership across all phases of clinical research.
Provide statistical input into development strategy, study design, sample size determination, endpoint selection, estimands, and analysis methodology.
Perform or oversee statistical analyses for interim study results, database locks, top-line results, and final clinical study reports.
Evaluate and implement innovative statistical methodologies, technologies, and AI-enabled tools to improve efficiency and quality across clinical development.
Develop and review statistical sections of clinical protocols, Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), Clinical Study Reports (CSRs), and other regulatory documents.
Ensure all statistical activities comply with ICH-GCP guidelines, CDISC standards, regulatory guidance, and company standards.
Contribute to the interpretation of clinical trial results and support the preparation of regulatory submissions, publications, scientific presentations, and responses to health authorities.
Represent Altimmune in interactions with external statistical vendors, CROs, and regulatory agencies.
Collaborate closely with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Affairs, and Regulatory Affairs to ensure high-quality study design and execution.
Work closely with statistical programmers to ensure timely development of analysis datasets, tables, listings, and figures (TLFs) supporting clinical development and regulatory submissions.
Review and validate statistical programming deliverables, programmatically or through independent review, as appropriate.
Oversee statistical activities performed by CROs and external vendors, ensuring quality, timeliness, and compliance with regulatory requirements.
Foster a culture of scientific rigor, collaboration, innovation, and continuous learning within the Biometrics organization.
Contribute to departmental process improvements, standards development, and cross-functional initiatives that strengthen Altimmune's clinical development capabilities.