Holly S.

My current role is as a senior project manager for biopharma where I drive and manage multiple project workstreams towards drug development and commercialization including research, CMC, process development/characterization, quality control, regulatory, supply chain, assay development, and market access. Duties include team management, strategy development support, resourcing, timeline creation and tracking, interfacing with senior leadership and regulatory team, technical writing and editing, budgets and accrual, contract management, direct experience with BLA preparation, inspection readiness, and FDA inspection support.

I served as project manager and challenge/app-a-thon lead supporting community development and engagement on the precisionFDA portal. Duties included project management support, budget, staff management, leading App-a-thons aimed at bioinformatics education, supporting the design of bioinformatics challenges to drive crowdsourced innovation, assisting in the creation of a subject matter specific communications plan, and testing and evaluating challenges. Prior to this role, I led a training team in the development of online laboratory safety training courses where I compiled laboratory safety best practices and ensured federal regulation compliance to create courses that incorporate adult learning concepts. In addition I both led and regularly participated in proposal development for new work at Booz Allen.

• Provide clinical, biological, and bioinformatics support to pharmaceutical, biotechnology, and biodefense industries according to client needs • Utilize statistical methodologies including linear regression models, linear mixed models, generalized linear models, generalized linear mixed models, non-linear models, and survival analysis • Quality control measures and analysis of next-generation sequencing data including RNA and DNA sequencing • Perform SAS program development for downstream analysis • Provide technical writing and review of for statistical analysis plans, statistical analysis reports, and regulatory documents. • Conduct work in accordance with BSSI standard operating procedures (SOPs), BSSI QA/QC policies, client-specific requirements and applicable regulatory guidelines • Participate in BSSI internal research projects • Collaborate with team members towards achieving company objectives

• Perform quality assurance/quality control reviews of clinical trial results submissions for consistency with review criteria • Communicate (via record reviews, teleconferences, emails, workshops, etc.) with clinical trial sponsors, principal investigators, and statisticians to facilitate understanding of and adherence to submission requirements • Create new documentation to help responsible parties submit their clinical trial results records • Devise and help implement strategies to improve the quality of submissions • Participate in weekly team meetings with NLM staff to discuss process improvement • Perform general editorial proofreading

• Self-funded to carry out research on lung cancer pharmacogenomics. Specifically, utilizing next generation sequencing technologies to examine differences in the tumors of African-American and Caucasian patients • Mentoring graduate students during their PhD work • Supporting role in analyses of statistical analysis of genetic data including cardiovascular and neuropsychiatric studies in an Old Order Amish population • Teaching genetics courses at a graduate school and medical school level • Oral presentations to my department regarding new genetic and statistical techniques • Preparation of first author publications and support for other publications

Genetic epidemiology of complex diseases, pharmacogenomics Program in Personalized Medicine, UMMC Statistical Geneticist

Association studies with single nucleotide polymorphisms (SNP) in the CHRNA5/CHRNA3/CHRNB4 gene cluster with conduct disorder-related phenotypes and substance use. Functional characterization of SNPs in this region utilizing gene expression assays. Dr. Marissa Ehringer, Advisor. Department of Integrative Physiology, University of Colorado, Boulder, CO.

Ph.D.) Dissertation: Fine mapping of the 15q13-14 schizophrenia linkage region * Designed a project to fine map 16 genes in the schizophrenia linkage region utilizing TagSNPs (1200+) to maximize the amount of genetic variation surveyed. * Obtained expertise in the SNPlex (Applied Biosystems) genotyping assay and clustering software. * Managed data (Microsoft Access) and analysis with various statistical genetics software packages including Haploview, UNPHASED, MERLIN, and QUANTO. * Designed an experiment to determine the degree of admixture in sample populations collected by the laboratory. * Selected appropriate ancestry informative markers, genotyped samples and analyzed data via STRUCTURE. * Presented results of research at three international meetings and contributed to several publications and grants

* Designed a study to determine the effective population size of the critically endangered Kemp's ridley sea turtle * Acquired expertise in animal handling and skin biopsy techniques. * Developed a novel minimally invasive tissue sampling technique for the Kemp's ridley sea turtle. * Obtained expertise in molecular biology techniques: DNA isolation, PCR, DNA electrophoresis, DNA sequencing, and microsatellite genotyping assays. * Analyzed data with the GENEPOP statistical genetics software.

Fine mapping of the 15q13-14 schizophrenia linkage region. Dr. Sherry Leonard, Advisor. Department of Psychiatry, University of Colorado Health Sciences Center, Aurora, CO.

Population genetics of the Kemp’s ridley sea turtle (Lepidochelys kempii). Dr. Jaime Alvarado-Bremer, Advisor. Department of Marine Biology, Texas A&M University, Galveston, TX.