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Senior Director, Biostatistics

May 26, 2026

<h2 style="text-align: justify;">Work Location: Hybrid or Remote</h2> 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. <h2 style="text-align: justify;">Essential Functions:</h2> <ul> <li style="text-align: justify; tab-stops: .5in;">Provide strategic statistical leadership for clinical development programs, including MASH and other indications.</li> <li style="text-align: justify; tab-stops: .5in;">Serve as lead statistician for one or more development programs and contribute to overall development strategy, study design, endpoint selection, and evidence generation plans.</li> <li style="text-align: justify; tab-stops: .5in;">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.</li> <li style="text-align: justify; tab-stops: .5in;">Lead development and review of statistical sections of protocols, SAPs, CRFs, clinical study reports, publications and regulatory submission documents.</li> <li style="text-align: justify; tab-stops: .5in;">Provide statistical input into regulatory interactions and contribute to IND, NDA, and BLA submissions, including responses to health authority questions.</li> <li style="text-align: justify; tab-stops: .5in;">Direct and oversee statistical analyses for interim analyses, DMC support, topline results, and final study analyses.</li> <li style="text-align: justify; tab-stops: .5in;">Ensure timely and high-quality delivery of statistical outputs, analyses, tables, listings, and figures to support clinical development and regulatory submissions.</li> <li style="text-align: justify; tab-stops: .5in;">Collaborate closely with statistical programming to ensure appropriate implementation of analyses and adherence to CDISC standards.</li> <li style="text-align: justify; tab-stops: .5in;">Oversee statistical activities and deliverables from CROs and external vendors, ensuring scientific rigor, operational excellence, and compliance with regulatory standards and internal processes.</li> <li style="text-align: justify; tab-stops: .5in;">Interpret clinical trial results and contribute to internal decision-making, governance discussions, publications, presentations, and external scientific communications.</li> <li style="text-align: justify; tab-stops: .5in;">Contribute to strategic planning, scenario evaluation, and go/no-go decision-making across programs.</li> <li style="text-align: justify; tab-stops: .5in;">Evaluate and implement innovative statistical methodologies and quantitative approaches to enhance clinical development programs.</li> <li style="text-align: justify; tab-stops: .5in;">Provide mentorship and technical guidance to statisticians and statistical programmers, including in areas related to AI/ML and advanced analytics.</li> <li style="text-align: justify; tab-stops: .5in;">Support departmental initiatives, process improvements, inspection readiness activities, and the continued evolution of the Biometrics function.</li> </ul> <h2 style="text-align: justify;">Job Requirements (Essential knowledge, skills, and attributes):</h2> <ul> <li style="text-align: justify; tab-stops: .5in;">PhD or Master's in Statistics, Biostatistics, or related MS with significant industry experience required</li> <li style="text-align: justify; line-height: 100%; tab-stops: .5in;">10+ years of experience in clinical trial statistics within biotech, pharmaceutical, or CRO environments, including late-stage clinical development experience.</li> <li style="text-align: justify; line-height: 14.65pt; tab-stops: .5in;">Strong understanding of statistical methods for clinical trials, including longitudinal data analysis, survival analysis, missing data methodology, estimands, adaptive designs, and Bayesian approaches.</li> <li style="text-align: justify; line-height: 14.65pt; tab-stops: .5in;">Demonstrated experience supporting regulatory interactions and major regulatory submissions (IND/NDA/BLA/MAA).</li> <li style="text-align: justify; line-height: 14.65pt; tab-stops: .5in;">Experience serving as lead statistician for complex clinical development programs.</li> <li style="text-align: justify; line-height: 14.65pt; tab-stops: .5in;">Strong knowledge of ICH-GCP, regulatory expectations, and industry standards, including CDISC (SDTM/ADaM).</li> <li style="text-align: justify; line-height: 14.65pt; tab-stops: .5in;">Proficiency in SAS and/or R.</li> <li style="text-align: justify; line-height: 14.65pt; tab-stops: .5in;">Excellent communication, collaboration, and leadership skills, with the ability to influence cross-functional teams and senior stakeholders.</li> <li style="text-align: justify; line-height: 14.65pt; tab-stops: .5in;">Ability to operate effectively in a fast-paced, entrepreneurial biotech environment with a balance of strategic thinking and hands-on execution.</li> <li style="text-align: justify; line-height: 14.65pt; tab-stops: .5in;">Experience managing and overseeing CROs and external statistical vendors.</li> </ul> Preferred Experience: <ul> <li style="text-align: justify; tab-stops: .5in;">Prior experience in liver disease or metabolic indications (e.g., MASH/NASH, obesity, diabetes).</li> <li style="text-align: justify; tab-stops: .5in;">Experience with external control arms, real-world evidence, or synthetic cohort methodologies.</li> <li style="text-align: justify; tab-stops: .5in;">Familiarity with non-invasive biomarkers, imaging endpoints, and emerging regulatory expectations in metabolic disease.</li> <li style="text-align: justify; tab-stops: .5in;">Exposure to AI/ML applications in drug development or advanced analytics.</li> </ul> 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.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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