Work Highlights

Colangelo Advisory Group, LLC.

Managing Principal Advisor

Pfizer Pharmaceuticals

Biometrics Director—AI Innovation & Design Lead

Owned actualization of digitally transformed operations for 1200+ statistical data scientists.  

Eli Lilly Pharmaceuticals

Statistics Advisor—Clinical Computing & Automation    

Owned plan & deliveries of CLUWE & computing solutions for 500+ statisticians & stat analysts. 

FBI Contractor via Lockheed Martin Information Systems

AFIS System Performance Analyst

Owned analyzing & advising FBI on simulated & observed AFIS performance for speed & quality. 

Univ. of South Carolina Institute for Families in Society 

Biostatistician & Epidemiologist

Owned advising PI on analytical methods & results to finalize models & targets for novel managed care. 

Pfizer SIGMA: 

* 1200+ user platform digitalizing operations to define, generate, curate, & audit statistical results for FDA.

* Business leader of 130-person program; architected future operations & capability; sold business case.

Pfizer SMART: 

* Biometrics digital innovation team advising both solution delivery & change management (OCM) teams.

* Shepherding 8 data scientists; sold case earning dedicated headcount; 3 in-flight AI/ML capabilities.

Pfizer BOTs: 

* Crowd-sourced business opportunities to imbed AI/ML & RPA across R&D; delivered 40+ clinical BOTs.

* Advised on ideation process, SME, & prioritization; translated opportunities into solution approaches.

Lilly CLUWE: 

* Custom, 2300-user analysis & reporting platform and migration of all clinical data from SDD to CLUWE.

* Business decision maker; future-state visionary; business architect; OCM advisor; aided business case.

Lilly TAFFY: 

* Custom application to digitize A&R specifications & automate generation of standard macro driver code.

* Business owner; co-led UX; visionary; architected updated operations; aided Digital to formalize & deploy.

Lilly DAFFY: 

* Informatics research into linked clinical data standards via graph DB to assess UI & operational value.

* Business owner; defined methods with vendor; yielded transformative outcome; catalyzed linked info.

Lilly GCP:  

* Ensured Stats systems, methods, results; launched judgment-based culture; 4 regulatory inspections. 

* Stats quality lead; guided team of 10; directed priority assessments & CAPA; management liaison.

Lilly CSA:  

* Internal CRO of pooled resources, synergized SME, & best practices that scaled Statistics operations. 

* Provided SME to finalize processes, roles, outputs; defined operational model; evangelized value.

Lilly TA Lead: 

* Lead statistical analyst for Phase 4 Endocrine TA; author of standard re-use modules; coordinate work.

* Principal SME on endocrine data, analysis methods, computing techniques, data quality, study endpoints.

FBI AFIS:  

* AI-driven, near-time ID of fingerprints revolutionized FBI & local crime fighting—as seen on CSI, NCIS, etc. 

* Defined a priori discrete-event simulations to inform AFIS design; defined & report live metrics to FBI.

USC IFS:  

* Evaluated case management models to define pilot on medically fragile foster care kids, before scaling.

* Curated SC Medicaid data; defined methods; conducted analyses; interpreted results; drafted reports.