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.
Summary of Position:
Reporting to the Chief Medical Officer, the Vice President of Biometrics provides strategic leadership and oversight for all statistical and data management activities supporting Altimmune's clinical development portfolio. This role defines and drives the statistical strategy for programs from early development through pivotal trials and regulatory submission - and in the future will drive real-world evidence generation and post-marketing activities - ensuring the scientific integrity of clinical trial design, analysis, and interpretation. The Vice President, Biometrics, oversees internal and external teams across biostatistics, data management, and statistical programming, and serves as a key partner in shaping cross-functional development plans for pemvidutide in MASH, AUD, and ALD. The position plays a central role in quantitative decision-making, regulatory interactions, and the application of statistical methodologies. Success requires exceptional scientific judgment, a strong regulatory track record, and the ability to communicate complex statistical concepts early across clinical, scientific, and executive stakeholders. Depending upon location, this role will be hybrid or remote and will require some travel as business needs dictate.
Essential Functions:
- Shape statistical strategy for clinical development programs, including endpoint selection, estimand frameworks, and overall statistical positioning to support program objectives and corporate milestones
- Evaluate, recommend, and implement innovative statistical techniques - including adaptive designs, Bayesian methods, enrichment strategies, and real-world evidence integration - to enhance trial efficiency and decision‑making
- Contribute to portfolio-level planning, including scenario modeling, probability of success assessments, quantitative risk evaluation, and go/no-go recommendations
- Oversee the development and governance of standard processes, systems, and infrastructure for biometrics, data management, and statistical analysis programming to ensure quality, consistency, and compliance
- Direct the development of statistical components of study protocols, statistical analysis plans, and review of statistical programming outputs to ensure accuracy and regulatory readiness
- Lead data collection, validation, management, and storage strategies that meet data standards and support high-quality regulatory submissions
- Serve as the senior statistical representative in regulatory interactions, contributing to briefing packages, responses, and advisory committee preparation
- Lead, mentor, and develop a high-performing biostatistics and data management team, fostering scientific excellence, accountability, and cross-functional collaboration
- Manage external partners and CROs to ensure high-quality, timely deliverables and alignment with internal standards and program needs
- Ensures timely and accurate delivery of clinical study data analyses to support program decisions, regulatory filings, and communication
- Interpret and communicate clinical trial data to internal and external stakeholders, contributing to scientific publications, presentations, and regulatory submission documents
Job Requirements (Essential knowledge, skills, and attributes):
- MS or PhD in Biostatistics, Statistics, or related quantitative field
- 15 or more years of industry experience in biotech or pharma
- At least 8 years' experience leading and developing high-performing teams
- Demonstrated success leading statistical strategy for pivotal trials and significant contributions to successful regulatory submissions (IND, NDA, BLA, MAA), with a strong track record of direct interaction with global health authorities.
- Proven ability to lead and scale teams, including remote and in-person teams
- Strong communication skills, both orally and in writing, with an ability to interpret and communicate statistical concepts and results clearly to non-statistical stakeholders, senior executives, investigators, vendors, and regulatory agencies.
- Deep expertise in clinical trial design and statistical methodology across all phases, including confirmatory trial methods, multiplicity control, missing data strategies, interim monitoring, estimand‑aligned analyses, and benefit–risk assessment
- Experience with innovative and complex designs such as adaptive trials, Bayesian methods, enrichment strategies, and integration of real‑world evidence
- Familiarity with modern data infrastructure, including CDISC standards, data visualization tools, and statistical programming environments; proficiency with SAS for complex analyses
- Proven ability to operate effectively in fast‑paced, entrepreneurial biotech settings, balancing scientific rigor with practical decision‑making
- History of successful collaboration in a team environment throughout the organization, with strong organizational skills and the ability to prioritize multiple competing demands
- Experience with Data Monitoring Committees and therapeutic experience in metabolic diseases preferred but not required.
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.