Senior Director, Biostatistics
Work Location: Hybrid or Remote
Reporting to the Vice President, Biometrics, the Senior Director, Biostatistics will provide strategic and technical statistical leadership across one or more clinical development programs within Altimmune's portfolio. This individual will serve as lead statistician for key development programs and collaborate closely with cross-functional teams, including Clinical Development, Clinical Science, Statistical Programming, Data Management, Regulatory Affairs, Medical Affairs, and Clinical Operations, to design, conduct, analyze, and interpret clinical studies across all phases of development.
The Senior Director will be responsible for the overall quality and scientific integrity of statistical strategy, study design, analyses, interpretation, and data reporting. This individual will contribute to regulatory interactions, oversee statistical activities performed in-house or by CROs and vendors, and play a key role in advancing innovative quantitative approaches to support clinical development and decision-making. Depending upon location, this role will be hybrid or remote and may require some travel as business needs dictate.
Essential Functions:
Provide strategic statistical leadership for clinical development programs, including MASH and other indications.
Serve as lead statistician for one or more development programs and contribute to overall development strategy, study design, endpoint selection, and evidence generation plans.
Partner cross-functionally with Clinical, Regulatory, Medical Affairs, Pharmacovigilance, Data Management, Statistical Programming, and Clinical Operations to ensure alignment on study objectives, analyses, and interpretation.
Lead development and review of statistical sections of protocols, SAPs, CRFs, clinical study reports, publications and regulatory submission documents.
Provide statistical input into regulatory interactions and contribute to IND, NDA, and BLA submissions, including responses to health authority questions.
Direct and oversee statistical analyses for interim analyses, DMC support, topline results, and final study analyses.
Ensure timely and high-quality delivery of statistical outputs, analyses, tables, listings, and figures to support clinical development and regulatory submissions.
Collaborate closely with statistical programming to ensure appropriate implementation of analyses and adherence to CDISC standards.
Oversee statistical activities and deliverables from CROs and external vendors, ensuring scientific rigor, operational excellence, and compliance with regulatory standards and internal processes.
Interpret clinical trial results and contribute to internal decision-making, governance discussions, publications, presentations, and external scientific communications.
Contribute to strategic planning, scenario evaluation, and go/no-go decision-making across programs.
Evaluate and implement innovative statistical methodologies and quantitative approaches to enhance clinical development programs.
Provide mentorship and technical guidance to statisticians and statistical programmers, including in areas related to AI/ML and advanced analytics.
Support departmental initiatives, process improvements, inspection readiness activities, and the continued evolution of the Biometrics function.
Job Requirements (Essential knowledge, skills, and attributes):
PhD or Master's in Statistics, Biostatistics, or related MS with significant industry experience required
10+ years of experience in clinical trial statistics within biotech, pharmaceutical, or CRO environments, including late-stage clinical development experience.
Strong understanding of statistical methods for clinical trials, including longitudinal data analysis, survival analysis, missing data methodology, estimands, adaptive designs, and Bayesian approaches.
Demonstrated experience supporting regulatory interactions and major regulatory submissions (IND/NDA/BLA/MAA).
Experience serving as lead statistician for complex clinical development programs.
Strong knowledge of ICH-GCP, regulatory expectations, and industry standards, including CDISC (SDTM/ADaM).
Proficiency in SAS and/or R.
Excellent communication, collaboration, and leadership skills, with the ability to influence cross-functional teams and senior stakeholders.
Ability to operate effectively in a fast-paced, entrepreneurial biotech environment with a balance of strategic thinking and hands-on execution.
Experience managing and overseeing CROs and external statistical vendors.
Preferred Experience:
Prior experience in liver disease or metabolic indications (e.g., MASH/NASH, obesity, diabetes).
Experience with external control arms, real-world evidence, or synthetic cohort methodologies.
Familiarity with non-invasive biomarkers, imaging endpoints, and emerging regulatory expectations in metabolic disease.
Exposure to AI/ML applications in drug development or advanced analytics.
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.
Apply To This Job
Reporting to the Vice President, Biometrics, the Senior Director, Biostatistics will provide strategic and technical statistical leadership across one or more clinical development programs within Altimmune's portfolio. This individual will serve as lead statistician for key development programs and collaborate closely with cross-functional teams, including Clinical Development, Clinical Science, Statistical Programming, Data Management, Regulatory Affairs, Medical Affairs, and Clinical Operations, to design, conduct, analyze, and interpret clinical studies across all phases of development.
The Senior Director will be responsible for the overall quality and scientific integrity of statistical strategy, study design, analyses, interpretation, and data reporting. This individual will contribute to regulatory interactions, oversee statistical activities performed in-house or by CROs and vendors, and play a key role in advancing innovative quantitative approaches to support clinical development and decision-making. Depending upon location, this role will be hybrid or remote and may require some travel as business needs dictate.
Essential Functions:
Provide strategic statistical leadership for clinical development programs, including MASH and other indications.
Serve as lead statistician for one or more development programs and contribute to overall development strategy, study design, endpoint selection, and evidence generation plans.
Partner cross-functionally with Clinical, Regulatory, Medical Affairs, Pharmacovigilance, Data Management, Statistical Programming, and Clinical Operations to ensure alignment on study objectives, analyses, and interpretation.
Lead development and review of statistical sections of protocols, SAPs, CRFs, clinical study reports, publications and regulatory submission documents.
Provide statistical input into regulatory interactions and contribute to IND, NDA, and BLA submissions, including responses to health authority questions.
Direct and oversee statistical analyses for interim analyses, DMC support, topline results, and final study analyses.
Ensure timely and high-quality delivery of statistical outputs, analyses, tables, listings, and figures to support clinical development and regulatory submissions.
Collaborate closely with statistical programming to ensure appropriate implementation of analyses and adherence to CDISC standards.
Oversee statistical activities and deliverables from CROs and external vendors, ensuring scientific rigor, operational excellence, and compliance with regulatory standards and internal processes.
Interpret clinical trial results and contribute to internal decision-making, governance discussions, publications, presentations, and external scientific communications.
Contribute to strategic planning, scenario evaluation, and go/no-go decision-making across programs.
Evaluate and implement innovative statistical methodologies and quantitative approaches to enhance clinical development programs.
Provide mentorship and technical guidance to statisticians and statistical programmers, including in areas related to AI/ML and advanced analytics.
Support departmental initiatives, process improvements, inspection readiness activities, and the continued evolution of the Biometrics function.
Job Requirements (Essential knowledge, skills, and attributes):
PhD or Master's in Statistics, Biostatistics, or related MS with significant industry experience required
10+ years of experience in clinical trial statistics within biotech, pharmaceutical, or CRO environments, including late-stage clinical development experience.
Strong understanding of statistical methods for clinical trials, including longitudinal data analysis, survival analysis, missing data methodology, estimands, adaptive designs, and Bayesian approaches.
Demonstrated experience supporting regulatory interactions and major regulatory submissions (IND/NDA/BLA/MAA).
Experience serving as lead statistician for complex clinical development programs.
Strong knowledge of ICH-GCP, regulatory expectations, and industry standards, including CDISC (SDTM/ADaM).
Proficiency in SAS and/or R.
Excellent communication, collaboration, and leadership skills, with the ability to influence cross-functional teams and senior stakeholders.
Ability to operate effectively in a fast-paced, entrepreneurial biotech environment with a balance of strategic thinking and hands-on execution.
Experience managing and overseeing CROs and external statistical vendors.
Preferred Experience:
Prior experience in liver disease or metabolic indications (e.g., MASH/NASH, obesity, diabetes).
Experience with external control arms, real-world evidence, or synthetic cohort methodologies.
Familiarity with non-invasive biomarkers, imaging endpoints, and emerging regulatory expectations in metabolic disease.
Exposure to AI/ML applications in drug development or advanced analytics.
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.
Apply To This Job