Government & research capabilities
Proven.
Biostatistics and clinical statistical programming for health-research primes, HHS programs, and state and local health agencies. 4.5 years across Phase I/II and Phase III clinical trials, including FDA IND submissions for rare-disease gene therapy programs and a late-stage oncology diagnostic trial.
- Small business
- Woman-owned
- Minority-owned
- Philadelphia, PA
- Gov purchase card accepted
Study phases supported
- Preclinical
- Phase I/II
- Phase III
Core competencies
Analysis dataset development
SDTM mapping, ADSL and ADaM variable derivation, and pre-analysis QC for analysis-ready subject-level datasets.
Independent validation
Verification of analysis datasets and outputs against production programming; TFLs for study reports and publications in SAS and R.
Study design and SAP development
Sample size, power, randomization schedules, and analysis methods; co-authored SAPs for preclinical and Phase I/II studies.
Clinical trial support, Phase I/II through Phase III
Statistical design, analysis datasets, and validated outputs from early-phase safety and dose studies through late-stage confirmatory trials.
Statistical modeling
Time-to-event and survival analysis, mixed models and repeated measures, generalized linear models, ANOVA, diagnostic accuracy.
Regulatory analysis support
Statistical analyses for FDA IND submissions under GCP; SOP development with QA and data management.
Large-scale data engineering
Migration and validation of 100,000+ file datasets; AWS S3, SQL, and Git-controlled pipelines.
For public health agencies
Health disparity analysis
Compare outcomes by race, income, neighborhood, or sex to show where programs should focus.
Program evaluation
Measure whether a program changed outcomes, with sample size planning so the study can answer the question.
Registry and records analysis
Clean, link, and analyze large registry, case, and administrative datasets.
Survey analysis
Community and population survey data turned into tables and dashboards staff can use.
Outcomes over time
Follow people or neighborhoods across years to see what improves and what does not.
Plain-language reporting
Clear charts and summaries for leadership, grant reports, and community meetings.
Past performance
Principal’s relevant experience
2026 to present
Late-stage oncology diagnostic company
Need: A Phase III trial needed analysis-ready data across 70,000+ records.
Work: Derived ADSL and ADaM variables, ran pre-analysis QC, built stratified medical review samples, and validated outputs against production.
Result: Supported database lock and public data releases on deadline.
2022 to 2025
Rare-disease gene therapy developer
Need: 15 preclinical and clinical programs, including Phase I/II studies, needed statistical design and analysis.
Work: Estimated sample sizes, co-authored 4 SAPs, ran time-to-event and mixed-model analyses, and produced TFLs in SAS and R.
Result: Supported 3 FDA IND submissions and 4 peer-reviewed publications.
2023
Digital health startup
Need: An AI speech-based impairment detection tool needed a defensible clinical validation design.
Work: Estimated sample size for a diagnostic accuracy study benchmarked against urine toxicology, under GCP.
Result: Delivered a study design ready for clinical validation.
2020 to 2022
Academic medical school
Need: Maternal health outcomes research using registry and CDC data.
Work: Cleaned, linked, and analyzed registry and CDC datasets.
Result: Results presented at the Columbia University Health Symposium.
Differentiators
- Woman- and minority-owned small business. Helps primes meet small business subcontracting goals.
- Design and programming under one roof. The same senior principal writes the SAP and builds the ADaM datasets, so you do not pay for two roles or lose context between them.
- Range across phases, drugs, and diagnostics. Preclinical and Phase I/II gene therapy work through FDA IND, plus Phase III diagnostic trial data.
- Peer-reviewed authorship. 4 publications in Nature Communications, Human Gene Therapy, and Cancer Gene Therapy; informatics SOPs still in use.
- Full statistical toolkit. SAS, R, Python, IBM SPSS, Stata, and MATLAB, plus machine learning tools for prediction and diagnostic modeling.
Company data
- Legal name
- Aspen Analytics LLC
- Primary NAICS
- 541690 · Other Scientific and Technical Consulting Services
- Other NAICS
- 541715 · R&D in Physical, Engineering, and Life Sciences
541720 · R&D in Social Sciences and Humanities
541714 · R&D in Biotechnology
541511 · Custom Computer Programming Services
541512 · Computer Systems Design Services
541519 · Other Computer Related Services
541430 · Graphic Design Services
541613 · Marketing Consulting Services - Business type
- Small business; woman-owned and minority-owned
- Payment
- Government purchase card and major credit cards
- Point of contact
- Kanyin Olateru-Olagbegi, MS
Founder & Principal Biostatistician
contact@aspendrivegroup.com
For prime contractors
Let’s team.
Looking for a woman- and minority-owned small business subcontractor for biostatistics, statistical programming, or data work? Send the solicitation or scope, and we’ll reply with fit and availability.