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Hire Lu Q.

United States

USD 150 /hr

Oncology Biostatistician | Clinical Trial Design | Biomarker Validation | 10 Years NCI Cancer Centers

Profile Summary

Senior biostatistician with 10 years of oncology clinical trial experience at NCI-designated cancer centers (Fred Hutchinson, Moffitt) and the SWOG Cancer Research Network. Core expertise: - Clinical trial design (Phase I–III): sample size, randomization, SAPs - Biomarker validation and early cancer detection study design - Adaptive and enrichment trial designs - Real-world evidence and causal inference methods - DSMB reporting and FDA regulatory submissions Recent work includes leading statistical design for NCI Early Detection Research Network (EDRN) studies and co-authoring a Cancer Letters (2024) publication on multi-site biomarker validation that improved pancreatic cancer detection sensitivity from 44% to 71%. Tools: R, SAS, SQL, Medidata Rave, CDASH/CDISC standards Available for: sample size calculations, SAP development, interim analyses, biomarker study design, and statistical consulting for grant applications.

Subject Matter Expertise

• ☆ Biostatistics
• ☆ Data Analysis
• ☆ Predictive Modeling & Analytics
• ☆ Cluster Analysis
• ☆ Data Visualization
• ☆ Pattern Recognition
• ☆ Statistics
• ☆ Applied Statistics
• ☆ Bayesian Statistics
• ☆ Study Design
• ☆ Health Data Analysis
• ☆ Decision Science
• ☆ Python
• ☆ SQL
• ☆ SAS
• ☆ LaTex
• ☆ R
• ☆ Clinical Trials
• ☆ Clinical Data Management
• ☆ Clinical Trials Data Analysis
• ☆ Public Health
• ☆ Epidemiology
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing
• ☆ Data-Driven Decision Making

Services

• Research
• Consulting
• Data & AI

Research Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Scientific and Technical Consulting

Data & AI Predictive Modeling, Statistical Analysis, Data Visualization, Data Insights

Work Experience

Senior Biostatistician

Fred Hutchinson Cancer Center

February 2015 - June 2025

Biostatistician

Moffitt Cancer Center and Research Institute

October 2015 - February 2019

Education

Statistics (College of Arts and Science)

American University

- August 2015

Bachelor of Business Administration / Communications

Winthrop University

August 2007 - May 2011

Certifications

• SAS Certified Advanced Programmer for SAS 9

  SAS Institute

  September 2014 - Present

• SAS Certified Base Programmer for SAS 9

  SAS Institute

  April 2014 - Present

Publications

JOURNAL ARTICLE

Chari ST, Wu B, Lopez C, Lustigova E, Chen Q, Van Den Eeden SK, Leimpeter AD, Fisher W, Wood A, Alexander AS, et al. (2025). Risk of Pancreatic Cancer in Glycemically Defined New-Onset Diabetes: A Prospective Cohort Study . Gastroenterology.

Haab B, Qian L, Staal B, Jain M, Fahrmann J, Worthington C, Prosser D, Velokokhatnaya L, Lopez C, Tang R, et al. (2024). A rigorous multi-laboratory study of known PDAC biomarkers identifies increased sensitivity and specificity over CA19-9 alone . Cancer letters.

Vaidya R, Unger JM, Qian L, Minichiello K, Herbst RS, Gandara DR, Neal JW, Leal TA, Patel JD, Dragnev KH, et al. (2023). Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP) . JCO precision oncology.

Unger JM, Qian L, Redman MW, Tavernier SS, Minasian L, Sigal EV, Papadimitrakopoulou VA, Leblanc M, Cleeland CS, Dzingle SA, et al. (2023). Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I . Journal of the National Cancer Institute.

Lacson JCA, Forgas SM, Doyle SH, Qian L, Del Rio J, Valavanis S, Carvajal R, Gonzalez-Calderon G, Kim Y, Roetzheim RG, et al. (2022). Assessment of melanoma precision prevention materials incorporating MC1R genetic risk information . Translational behavioral medicine.

Lacson JCA, Doyle SH, Qian L, Del Rio J, Forgas SM, Valavanis S, Carvajal R, Gonzalez-Calderon G, Kim Y, Roetzheim RG, et al. (2021). A Randomized Trial of Precision Prevention Materials to Improve Primary and Secondary Melanoma Prevention Activities among Individuals with Limited Melanoma Risk Phenotypes . Cancers.

Lacson JCA, Zamani SA, Froes LAR Jr, Mitra N, Qian L, Doyle SH, Azizi E, Balestrini C, Bishop DT, Bruno W, et al. (2021). Birth cohort-specific trends of sun-related behaviors among individuals from an international consortium of melanoma-prone families . BMC public health.

Lamm SH, Ferdosi H, Boroje IJ, Afari-Dwamena NA, Qian L, Dash ED, Li J, Chen R, Feinleib M (2020). Maternal tobacco use: A third-trimester risk factor for small-for-gestational-age pregnancy outcome . Preventive medicine reports.

Taylor NJ, Mitra N, Qian L, Avril MF, Bishop DT, Bressac-de Paillerets B, Bruno W, Calista D, Cuellar F, Cust AE, et al. (2019). Estimating CDKN2A mutation carrier probability among global familial melanoma cases using GenoMELPREDICT . Journal of the American Academy of Dermatology.