Director, Biostatistics

Altimmune; Morristown (NJ); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Altimmune is seeking a senior statistician to serve as lead statistician for one or more clinical development programs. You will collaborate with clinical teams to plan, conduct, and analyze studies across all phases, ensuring quality of statistical design and data reporting.

You will interact with regulators, external vendors, and cross-functional teams, applying rigorous statistical methods and driving methodology innovations in a high-impact environment.

Qualifications

• PhD in Statistics, Biostatistics, or related field with 7+ years of experience or MS with 10+ years of equivalent industry experience.
• Strong knowledge of statistical methods for clinical trials including longitudinal data, survival analysis, and Bayesian approaches.
• Experience with regulatory interactions and FDA/EMA expectations for statistical evidence.
• Proficiency in SAS and/or R; extensive CDISC SDTM/ADaM experience.
• Excellent communication and leadership abilities; ability to explain complex stats to non-statisticians.

Responsibilities

• Serve as the lead statistician for clinical development programs across phases.
• Provide statistical input into study design, estimands, and analysis methodologies.
• Oversee analyses for interim results, database locks, top-line results, and CSRs.
• Collaborate with vendors, CROs, and regulatory agencies as needed.

Skills

Statistical leadership

SAS & R

CDISC SDTM/ADaM

ICH-GCP compliance

Regulatory submissions

Communication skills

Team leadership

Education

PhD in Statistics/Biostatistics

MS in related field

Tools

SAS

R

CDISC tooling

Job description

About Altimmune:

Altimmune (NASDAQ: ALT) is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual‑action therapy targeting both glucagon and GLP‑1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction‑associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol‑associated liver disease (ALD). For more information, please visit www.altimmune.com.

Job Position: This is a high‑visibility, high‑impact role that will be critical to Altimmune’s growth. Reporting to the Senior Director, Biostatistics, this individual will provide statistical leadership and serve as the lead statistician for one or more clinical development programs within Altimmune’s pipeline. The role involves collaborating with clinical and development teams, including clinicians, clinical scientists, statistical programmers, data managers, regulatory, and clinical operations professionals, to plan, conduct, and analyze clinical studies of all phases. Responsibilities include ensuring the overall quality of statistical design, programming, analysis, and data reporting, representing the company in interactions with external statistical and data management service providers, and participating in discussions with regulatory agencies.

Workplace Designation: Depending upon location, this role will be hybrid or remote and will require some travel as business needs dictate.

Essential Functions

Statistical Leadership

• Serve as the lead statistician for one or more clinical development programs, providing statistical 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.

Regulatory and Documentation

• 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.

Cross‑Functional Collaboration

• 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.

Team Development and Process Excellence

• 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.

Job Requirements (Essential knowledge, skills, and attributes)

• 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

Preferred Experience

• 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.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.