Biostatistics and Clinical Trials Advisor

Biostatistics and Clinical Trials Advisor
The Opportunity:

To achieve an organization's mission, leaders need strong team members who can create processes, communicate requirements, and develop innovative solutions throughout the execution of the mission. Whether completing an immediate task, recognizing a process gap, recommending a solution, or flexing to support an immerging requirement, our clients need a consultant who can help manage operations while managing responses to external inquiries in a timely manner. That is why we need you, an experienced Biostatistics and Clinical Trials Advisor, to provide technical expertise and project development for emerging opportunities within healthcare.

As part of our team, you'll serve as a strategic technical consultant to the Advanced Research Projects Agency for Health (ARPA-H), helping conceptualize, create, and execute advanced government-funded research and development programs to accelerate better health outcomes for everyone. Work with world-class scientists and engineers to support the development of high-impact solutions to society's most challenging health problems. Leverage technical expertise to provide strategic assessments of new technologies in support to senior ARPA-H decision makers. Maintain responsibility for producing and presenting findings and recommendations to a team of colleagues and clients on the feasibility and potential impact of future research programs, assisting with the management of current programs, and facilitating commercialization of successfully developed technologies.

You'll serve as a Biostatistics and Clinical Trials Advisor helping clients to develop stakeholder management strategies, establish new business processes, and complete research and analysis to determine viable solutions. You will be responsible for managing incoming requirements, facilitating engagements within offices and across the Agency, and being readily available to shift your focus to fulfill emerging client requests. Your attention to detail, flexibility, communication skills, understanding of the client's mission, and problem-solving will enable the mission's success.

What You'll Work On :

• Support strategy development and program execution for biostatistics, clinical trials, artificial intelligence/machine learning for clinical trials, and computational modeling initiatives
• Offer deep technical insight into the design and evaluation of clinical trials, including innovative approaches such as adaptive, platform, digital twins, or in silico clinical trial simulations
• Advise on quantitative and statistical modeling for pharmacology, including Bayesian, frequentist, and empirical modeling approaches
• Evaluate the credibility and standards for computational and physics-based models for drugs, biologics, and advanced therapeutics, such as Quantitative Systems Pharmacology, Pharmacokinetic/Pharmacodynamic, or digital twin
• Coordinate with federal stakeholders and other interagency partners to support the development, evaluation, and transition of new drug clinical trial projects
• Evaluate the conceptual and technical soundness of research programs spanning biostatistics, clinical trials, artificial intelligence/machine learning for clinical trials, and computational modeling
• Assist in defining program goals, technical milestones, budgets, and performer expectations for high-impact scientific initiatives; conduct technical reviews of performer progress to ensure alignment with ARPA-H objectives
• Interact with clients, government officials, and other executives in various sectors

Join us. The world can't wait.

You Have:

• 3+ years of experience building physics-based and mechanistic models for drugs or biologics
• 1+ years of experience supporting new drug clinical trials of any phase for products regulated by FDA CDER or CBER, such as drugs, biologics, or advanced therapies
• Experience with Bayesian, frequentist, and empirical methods
• Experience supporting and advising government leadership or federal research programs
• Knowledge of biostatistics and statistical modeling
• Knowledge of clinical trial design
• Ability to manage budgets, technical milestones, and multidisciplinary research efforts across multi-site or multi-performer programs
• Doctorate degree in Biostatistics, Bioinformatics, Computational Biology, Epidemiology, or a Biomedical or Health Sciences field

Nice If You Have:

• Experience with disease- or patient-specific digital twin models
• Experience with in silico clinical trial simulations, specifically clinical trial optimization via in silico simulations
• Experience with synthetic data generation to augment real control patients in clinical trials
• Experience in the development or evaluation of artificial intelligence/machine learning approaches
• Experience with innovative clinical trial design approaches such as adaptive and platform trial designs
• Experience with assessing the credibility or development of standards for computational and physics-based models such as Quantitative Systems Pharmacology (QSP) and Pharmacokinetic/Pharmacodynamic (PK/PD) models
• Experience operating within a government environment and supporting senior federal leaders
• Ability to manage multiple priorities at once
• Possession of excellent communication skills

Compensation

At Booz Allen, we celebrate your contributions, provide you with opportunities and choices, and support your total well-being. Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care. Our recognition awards program acknowledges employees for exceptional performance and superior demonstration of our values. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in Booz Allen's benefit programs. Individuals that do not meet the threshold are only eligible for select offerings, not inclusive of health benefits. We encourage you to learn more about our total benefits by visiting the Resource page on our Careers site and reviewing Our Employee Benefits page.

Salary at Booz Allen is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The projected compensation range for this position is $86,800.00 to $198,000.00 (annualized USD). The estimate displayed represents the typical salary range for this position and is just one component of Booz Allen's total compensation package for employees. This posting will close within 90 days from the Posting Date.

Identity Statement

As part of the hiring process, we will ask you to complete an identity verification process that leverages advanced biometrics and artificial intelligence to ensure authenticity and protect against identity fraud. You are expected to be on camera during interviews and assessments. We reserve the right to take your picture to verify your identity and prevent fraud.

Candidate AI Usage Policy

AI is a part of our daily work at Booz Allen, and we are committed to the responsible and ethical use of AI tools. However, we want to ensure a fair candidate process based on your own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) or other tools to assist with responses during interviews (whether in-person or virtual) is prohibited unless permission is explicitly provided .

Work Model
Our people-first culture prioritizes the benefits of collaboration, whether it occurs in person or virtually. To support engagement and effective communication, employees working virtually are generally expected to have their cameras on during meetings.

• Remote : If this position is listed as remote, there may still be occasions when you are required to work in person at a Booz Allen or customer facility.
• Hybrid : If this position is listed as hybrid, you will be expected to work from a Booz Allen facility frequently, in alignment with leadership expectations and the needs of the role. You may also be required to work from or visit a customer facility.
• Onsite : If this position is listed as onsite, work will primarily be performed at a Booz Allen office or customer facility, where employees will collaborate directly with colleagues and customers as required by the role.

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to disability, status as a protected veteran or any other status protected by applicable federal, state, local, or international law.