Carina Spicer, Mphil, Ms, Pmp Email & Phone Number

Philadelphia, PA, US

North Wales, Pennsylvania, United States

North Wales, Pennsylvania, United States

Asset Project Manager for a late phase development team. Integrates cross-functional stakeholders to drive program strategy and progression.

North Wales, PA

Project Planner for development teams across different therapeutic areas. Maintained cross-functional program schedule and generated Gantt charts in OnePager to support streamlined and efficient program progression.

West Point, PA

• Internal consultant to multiple teams supporting vaccine production and packaging. Provided guidance on process control, qualification of novel materials, and manufacturing investigations to ensure high product quality.
• Support various statistical needs of vaccine manufacturing processes including establishing control limits and qualification or validation of new or updated reagents and machinery to maintain process accuracy and.
• Conduct data analysis of manufacturing investigations to understand abnormalities in the production process and provide guidance on mitigation to maintain the high quality of Merck vaccines.
• Effectively communicate statistical analyses conducted in R or JMP to scientific and engineering collaborators in a common language using presentations and formal reports.
• Wrote and implemented an R Markdown template to streamline and organize the generation of formal statistical reports, minimizing the potential for copying-and-pasting errors and expediting the second person review.

Cambridge, MA

• Collaborated with researchers across multiple therapeutic areas to design laboratory experiments and analyze results. Optimized use of research budgets by promoting programs with objective demonstrated efficacy.
• Designed statistically-powerful preclinical experiments, minimizing need to repeat assays and reducing the waste of experimental samples, laboratory animals, and research funding.
• Assessed endpoint variability using pilot experimental data and calculates powerful sample sizes for in vivo studies.
• Determined the appropriate statistical analysis for in vivo and in vitro studies to assess preclinical compound efficacy for small and large sample sizes in R, SAS, and GraphPad Prism.
• Conducted statistical analyses appropriate for each endpoint with timely turnaround using linear, generalized linear, nonparametric, repeated measures, and mixed model regression, among others.
• Constructed biologically-informed analyses by strengthening knowledge of project-specific science through consultation with scientists and independent research to be an integrated member of the project team.

Philadelphia, PA

• Conducted bioinformatic analysis of Single Nucleotide Variants (SNVs) and Copy Number Variants (CNVs)
• Implemented logistic regression models to determine predictive quality of genetic variants in multiple neurological disorders
• Assessed overlap between implicated genes across pediatric neurological disorders using inverse-chi-square meta-analysis

King Of Prussia, PA

• Validated and replicated dry-run tables and figures from Contract Research Organization (CRO) analysis of data from a Phase III Clinical Trial. Collaborated with CRO to resolve discrepancies to ensure accurate.

King Of Prussia, PA

• Designed a bootstrap simulation algorithm in R to model and optimize recruitment for a Phase III Clinical Trial of a novel analgesic therapy, ensuring the trial population was representative of the target patient.
• Generated and updated summary graphics of the patient population characteristics throughout recruitment and interpreted these findings to the clinical team to modulate recruitment practices for increased diversity.

Philadelphia, PA

• Assisted with instruction of SAS programming to students without prior programming experience
• Worked with students one-on-one to troubleshoot error messages and construct code
• Graded coding homework assignments and provided clear, timely feedback

New Haven, CT

• Cleaned and analyzed data from a preliminary clinical study using linear regression and mixed models.
• Provided regular updates of the analysis status to the project team to maintain an effective and collaborative relationship.
• Developed a clear report of statistical methods and results for the clinical principal investigator and presented statistical findings at center-wide meetings to guide project development.

New Haven, CT

• Measured fetal mouse gene expression in response to the presence or absence of maternal gut microbiota in utero using RNA-seq to determine the impact of maternal microbes on offspring gene expression.
• Collaborated with post-docs and the germ-free animal facility director to design and coordinate multiple, simultaneous, complex, long-term, germ-free mouse experiments.
• Assembled and implemented a Linux- and R-based RNA-seq analysis workflow on high-performance Linux computing cluster and collaborated with the computing center to make the pipeline accessible to all members of the lab.
• Presented research findings in posters and presentations at conferences and seminars to establish collaboration with scientists in different specialties, tailoring the information to diverse audiences.

New Haven, CT

• Instructed students on the basics of Linux, Python, R, and how to process genomic data using industry-standard tools on a high-performance computing cluster
• Collaborated with co-teaching fellow to redesign course curriculum and homework assignments
• Developed and executed lesson plans to present genomic tools to graduate students without prior experience

London, United Kingdom

• Contributed to the acceptance of Non-Invasive Prenatal Testing (NIPT) by the UK’s National Health Service (NHS) through experimental studies testing for fetal sex and Down Syndrome in maternal plasma samples.
• Managed maternal plasma samples and database for cell-free fetal DNA Biobank for research
• Sequenced patient DNA and analyzed mutations in MLL2 gene for Kabuki Syndrome
• Assisted diagnosticians in managing patient samples and designing a diagnostic molecular test for Netherton Syndrome

Allentown, Pennsylvania

• Generated mutant yeast strains for studying repair of DNA breakage and viability in response to UV radiation
• Manipulated both bacterial and yeast genetics to induce novel antibiotic resistances in cells

Master’S Degree (M.S.), Biostatistics

Master Of Philosophy (M.Phil.), Genetics

Bachelor Of Science (B.S.), Magna Cum Laude, Biological Sciences

Concentration in Cellular Biology, Molecular Biology, Genetics, and Biochemistry