Technical SETA (Biostatistics)

Valiant Harbor International is a CVE Service-Disabled Veteran Owned Small Business that specializes in technical, programmatic, acquisition, compliance, and financial services for Government science and technology, research and development, and technological programs. At Valiant Harbor International, we emphasize our intense focus on helping federal government agencies identify and address organizational challenges to tailor and integrate specific solutions to solve their most difficult problems. Success is defined by our ability to meet our customers’ needs quickly, efficiently, and effectively.

Valiant Harbor International is seeking a Technical SETA (Biostatistics) to support the Advanced Research Projects Agency for Health (ARPA-H) Proactive Health Office (PHO). The Technical SETA will support strategy development and program execution for biostatistics, clinical trials, AI/ML for clinical trials, and computational modeling. This is a remote opportunity that may require occasional travel.

Key Responsibilities:

• Application of knowledge of biostatistics and statistical modeling. Comfort with Bayesian, frequentist, and empirical methodologies required.
• Provides support to new drug clinical trials in all phases of development (i.e., for any product regulated by CDER or CBER, i.e., drugs, biologics, advanced therapies).
• Executes and clinical trial design in support of program officers and research teams.
• Supports and provides for the building of physics-based and mechanistic models for drugs/biologics.

Required Qualifications:

• PhD in a related field is required.
• Demonstrated expertise in biostatistics and statistical modeling (varying methodologies / types).
• Experience advising government leadership or supporting federal programs.
• Exceptional written and verbal communication skills.

Preferred Qualifications:

• Experience in disease-specific and patient-specific digital twin modeling.
• Demonstrated expertise in biostatistics and statistical modeling (varying methodologies / types).
• Experience in clinical trial optimization via in silico simulations.
• Experience with pharmacokinetics (PK) and pharmacodynamics (PD) modeling and simulation to predict how a drug moves through the body and how much biological effect it produces over time.
• Demonstrated experience with quantitative systems pharmacology (QSP) utilizing a computational and mathematical modeling approach that combines drug properties with the mechanistic study of biological systems and disease processes.
• Experience utilizing and evaluating AI/ML approaches.
• Demonstrated experience in innovative clinical trial design (adaptive clinical and platform trial designs).
• Experience developing standards for computational models and required datasets.
• Experience working across multi-institution or multi-performer programs.
• Experience working in early-stage, fast-paced, startup environments.
• Experience with federal funding.

Work Environment: Remote. Some travel anticipated.

Salary Range: Negotiable

EEO Statement: Valiant Harbor International, LLC is an Equal Opportunity/Affirmative Action employer. Valiant Harbor International prohibits discrimination with respect to the hiring or promotion of individuals, conditions of employment, disciplinary and discharge practices, or any other aspect of employment on the basis of sex, race, color, age, national origin, religion, disability, marital status, sexual orientation, gender identity, pregnancy, veteran status, or any other protected class. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Show phone number for  assistance.