Melissa Hicks
Philadelphia,PA
Summary
Principal Biostatistician with 10 years of experience in biostatistics and statistical programming supporting clinical research studies in pharmaceuticals, biotechnology, medical devices, and consumer health. Experienced in study design, statistical analysis, SAS programming, CDISC implementation, and regulatory submissions. Strong background in pharmacokinetics, pharmacodynamics, bioequivalence, noncompartmental analysis, and development of SAS macros and automated programming tools. Combines hands-on programming expertise with statistical leadership, allowing projects to be supported from protocol and SAP development through analysis, reporting, and submission.
Overview
11
11
years of professional experience
Work History
Principal Biostatistician
TKL Research
Fair Lawn, NJ
01.2024 - 05.2026
- Served as lead biostatistician for Phase I clinical studies, providing statistical and programming oversight from protocol development through final reporting and regulatory submission.
- Led statistical support for pharmacokinetic and pharmacodynamic studies, including SAD, MAD, bioequivalence, food-effect, dose proportionality, and PK/PD evaluations.
- Served as the primary statistical contact for sponsors, providing guidance on study design, endpoint definitions, SAP development, analysis methodologies, interpretation of results, and regulatory reporting.
- Directed and reviewed the work of statistical programmers to ensure accurate implementation of analysis specifications, ADaM datasets, tables, listings, figures, and PK parameter derivations.
- Designed analysis datasets and specifications and led programming validation efforts to ensure compliance with CDISC standards, SAP requirements, and regulatory expectations.
- Developed Statistical Analysis Plans (SAPs), TLF shells, analysis specifications, define.xml documentation, and statistical sections of Clinical Study Reports (CSRs).
- Designed, programmed, validated, and interpreted key PK analyses in SAS, including Cmax, Tmax, AUC0-t, AUC0-∞, λz, t1/2, CL/F, Vz/F, accumulation ratios, and steady-state assessments.
- Performed statistical analyses using ANOVA, mixed-effects models, and bioequivalence methodologies, including geometric mean ratio estimation and construction of 90% confidence intervals.
- Reviewed protocols, CRFs, bioanalytical datasets, SDTM datasets, ADaM datasets, TLFs, and CSRs to ensure consistency, scientific accuracy, and regulatory readiness.
- Developed a custom SAS macro to automate λz and half-life estimation using dynamic tail selection, regression diagnostics, and conditional trimming, improving efficiency, reproducibility, auditability, and quality of PK analyses.
- Mentored junior statisticians and programmers and collaborated with Clinical Operations, Data Management, Medical Writing, Pharmacokinetics, and Regulatory Affairs to resolve complex analytical and programming challenges.
Clinical Biostatistician II
TKL Research
Fair Lawn, NJ
06.2019 - 12.2023
- Led statistical analyses for Phase I studies including SAD, MAD, bioequivalence, food-effect, and pharmacokinetic evaluations.
- Authored SAPs, TLF shells, and analysis specifications in collaboration with clinical, data management, and programming teams.
- Developed and validated SAS programs for SDTM and ADaM datasets, TLFs in accordance with SAP and CDISC requirements.
- Performed independent validation of analysis datasets and statistical outputs to ensure accuracy, reproducibility, and regulatory compliance.
- Reviewed protocols, CRFs, ADaM datasets, TLFs, define.xml documentation, and CSRs to ensure consistency and submission readiness.
- Generated randomization schedules for crossover and parallel-group studies and provided statistical review of study documents and deliverables.
Clinical Biostatistician I
TKL Research
Fair Lawn, NJ
06.2017 - 05.2019
- Authored SAPs, TLF shells, programming specifications, and statistical sections of CSRs.
- Performed sample size calculations and generated randomization schedules for clinical studies.
- Programmed and validated SDTM datasets, ADaM datasets, tables, listings, and figures using SAS and CDISC standards.
- Conducted statistical analyses and supported data review activities for Phase I clinical studies.
- Prepared CDISC submission packages and validation reports using Pinnacle 21.
- Supported PK analyses, bioequivalence studies, and development of regulatory-compliant datasets and deliverables.
- Contributed to process improvements, programming standards, and documentation best practices.
Statistical Programming Intern
Quintiles IMS
Durham, NC
01.2017 - 06.2017
- Collaborated with biostatisticians and statistical programmers to develop and validate statistical outputs for Phase II–III clinical trials across multiple therapeutic areas.
- Performed quality control and validation of analysis datasets, tables, listings, and figures to ensure accuracy and consistency.
- Assisted in the development of CDISC-compliant SDTM and ADaM datasets and supporting define.xml documentation for regulatory submissions.
- Contributed to programming specifications, validation documentation, and internal quality processes supporting global pharmaceutical clients.
Biostatistics Graduate Research Assistant
University of North Carolina
Chapel Hill, NC
08.2015 - 06.2017
- Provided statistical programming and analytical support for OPPERA, a large NIH-funded longitudinal study investigating risk factors for chronic orofacial pain.
- Used SAS and R to perform data management, data cleaning, imputation, descriptive analyses, and exploratory analyses across large longitudinal datasets.
- Developed data dictionaries, analysis documentation, and reproducible programming workflows to support research transparency and data integrity.
- Collaborated with investigators from epidemiology, dentistry, pain research, and biostatistics to support study analyses and interpretation of findings.
- Presented analytical results and methodological recommendations to multidisciplinary research teams and contributed to scientific publications and presentations.
Education
MS - Biostatistics
University of North Carolina
Chapel Hill, NC05-2017
BA - Mathematics
Columbia University
New York, NY05-2015
Skills
- SAS (Base, Macro, SQL, STAT, Graph), R, Python
- CDISC (SDTM, ADaM), Definexml, Pinnacle 21
- Pharmacokinetics (PK), Pharmacodynamics (PD), Bioequivalence (BE), Noncompartmental Analysis (NCA)
- FDA & EMA Regulatory Submissions
Timeline
Principal Biostatistician
TKL Research
01.2024 - 05.2026
Clinical Biostatistician II
TKL Research
06.2019 - 12.2023
Clinical Biostatistician I
TKL Research
06.2017 - 05.2019
Statistical Programming Intern
Quintiles IMS
01.2017 - 06.2017
Biostatistics Graduate Research Assistant
University of North Carolina
08.2015 - 06.2017
MS - Biostatistics
University of North Carolina
BA - Mathematics
Columbia University