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

Strategic Analysis, Inc. (SA) is actively seeking a Technical SETA to 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 knowledge
4. Experience building physics-based and mechanistic models for drugs/biologics

Preferred Experience:

Any of the experiences below are preferred:
1. Disease-specific digital twin models
2. Patient-specific digital twin models
3. 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 trials
5. AI/ML approaches. AI/ML evaluation. Causal inference
6. Innovative clinical trial design: adaptive clinical trial designs, platform trial designs
7. PK/PD modeling and simulation
8. QSP
9. Credibility assessment of computational models
10. Standards development for computational models and required datasets.

Qualifications: 
1. PhD in related field
2. Strong quantitative and statistical expertise
3. Experience advising government leadership or supporting federal programs
4. Exceptional written and verbal communication skills

Preferred Qualifications:
1. Prior experience in technical advisory, evaluation, or SETA-style roles
2. Experience working across multi-institution or multi-performer programs
3. Experience working in early-stage, fast-paced, startup environments
4. Experience with federal funding

Location: Position is remote. 

Travel:  Periodic travel may be required

Clearance: Ability to obtain HHS Public Trust.

Equal employment opportunity, including veterans and individuals with disabilities.

PI286010203