Technical SETA for Biostatistics, Clinical Trials (#26-132)

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26-132

Washington, D.C.

Full Time

Public Trust

$140k-$180k

Strategic Analysis, Inc. (SA) is actively seeking aTechnical SETAto aid in the strategy development of new programs that leverage biostatistics, clinical trials, AI/ML for clinical trials, computational modeling. This is a Science and Engineering and Technical Advisor (SETA) role in support of the Advanced Research Projects Agency for Health (ARPA-H).Required Experience:1. Working knowledge of biostatistics and statistical modeling. Comfort with Bayesian, frequentist, and empirical methods.2. Experience supporting new drug clinical trials of any phase (i.e., for any product regulated by CDER or CBER, i.e., drugs, biologics, advanced therapies).3. Clinical trial design experience / working knowledge4. Experience building physics-based and mechanistic models for drugs/biologicsPreferred Experience:Any of the experiences below are preferred:1. Disease-specific digital twin models2. Patient-specific digital twin models3. In silico clinical trial simulations, clinical trial optimization via in silico simulations.4. Synthetic data generation: experience with exploring generation and evaluation of synthetic/virtual controls to augment real control patients in clinical trials5. AI/ML approaches. AI/ML evaluation. Causal inference6. Innovative clinical trial design: adaptive clinical trial designs, platform trial designs7. PK/PD modeling and simulation8. QSP9. Credibility assessment of computational models10. Standards development for computational models and required datasets.Qualifications:1. PhD in related field2. Strong quantitative and statistical expertise3. Experience advising government leadership or supporting federal programs4. Exceptional written and verbal communication skillsPreferred Qualifications:1. Prior experience in technical advisory, evaluation, or SETA-style roles2. Experience working across multi-institution or multi-performer programs3. Experience working in early-stage, fast-paced, startup environments4. Experience with federal fundingLocation: Position is remote.Travel: Periodic travel may be requiredClearance: Ability to obtain HHS Public Trust.

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