• Provides biostatistical leadership to cross-functional team including Medical Affairs, Market Access, Commercial and other functions to identify and generate critical evidence needed for strategic planning and to inform business decisions.• Drives the development, coordination, execution, and validation of statistical analyses of clinical trial data in support of strategic planning, including oversight of the work of statistical programmers and external vendors as needed. • Utilizes R and SAS to conduct novel statistical analyses such as MAIC for comparative effectiveness evidence generation in support of market access.• Provides statistical expertise as required for external engagement with consultants, advisory boards, health authorities, and payors; supports development of secondary publications and scientific congress deliveries including data visualizations.• Provides statistical input and review of marketing, sales, medical education and training materials pertaining to clinical study data and product claims.• Guides and supports the Medical Affairs team when investigator initiated trial proposals are received to ensure proposals of high quality and aligned with business strategy• Provides updates to internal stakeholders on Medical Affairs activities; supports annual budget and planning process.• Develops infrastructure for proposal submission and tracking, quality control and programming activities.

• Served as lead biostatistician for cross-functional project teams on Phase I/II clinical studies for multiple oncology indications. • Developed statistical analysis plans and reporting specifications for simple to complex clinical studies.• Reviewed statistical analyses of other statisticians and programmers and interpreted results from simple to complex clinical studies.• Performed senior review of statistical analysis plans, SDTM, and ADaM specifications and programming, TFL programming and outputs.• Serveed as an independent reporting statistician on data monitoring committees.• Provided significant input in the development and review of CRFs, edit specifications, variable derivations and critical variable lists.• Contributed to clinical study protocols and clinical study reports.• Reviewed simple to complex randomization specifications and dummy randomization schemes.• Performed sample size calculations using various platforms and techniques including Bayesian approaches. • Created and monitored study timelines, conducted forecasting, effort resourcing and budgeting for biostatistics team throughout study. • Contributed to and participated in bid defense meetings, study kick-off meetings and SAP review meetings with clients.• Interfaced with clients and study teams to provide statistical guidance and leadership, solve issues and ensure quality and on-time deliverables.• Trained and mentored new or junior statisticians on statistical methods and PRA systems and procedures.

• Served as lead biostatistician and programmer for phase I-III clinical trials and real-world/observational studies.• Determined appropriate statistical methodology for and conducted analyses using observational datasets such as SEER, SEER-Medicare, National Cancer Database and clinical trial data for health outcomes insights using SAS and R. • Managed all statistical aspects of studies including protocol development, CRF specifications, writing statistical analysis plans, data quality control, analysis and reporting; monitored data collection for ongoing clinical trials and instituted procedures to assure data quality and adherence to study protocols.• Programmed and interpreted basic and advanced statistical analyses using SAS and R including descriptive, nonparametric, survival, regression, generalized linear models, longitudinal, mixed models, meta-analysis, random effects and propensity score adjustment, causal analysis and other methodologies. • Produced reproducible analytic output using R Markdown and SAS ODS output; prepared complex visualization of results in R, SAS and Tableau.• Prepared presentations, abstracts, manuscripts, abstracts and final study reports.• Prepared Data and Safety Monitoring Board reports.• Interfaced with study team as the lead biostatistician; attended team meetings and represented departmental needs for assigned projects.• Mentored and provided training and support to junior staff.

• Acted as lead biostatistician to support investigator-initiated trials from concept through execution of studies utilizing retrospective data and biospecimens from large longitudinal oncology studies, tumor registries and electronic medical records. • Conducted analysis of patient-reported outcomes from multiple QOL instruments.• Facilitated appropriate cohort search, discovery and definition for specific research questions including power and sample size considerations. • Selected appropriate statistical methods and conducted statistical analyses utilizing SAS. Generated descriptive and analytic statistics and visualizations.• Wrote statistical text for study reports, grants and clinical publications. Prepared methods sections and analysis plans for incorporation in abstracts, manuscripts, reports and grants.

• Lead biostatistician and programmer for health outcomes research in oncology (prostate cancer).• Conducted analyses utilizing large observational datasets including Surveillance, Epidemiology and End Results (SEER)-Medicare, Medicare and Medicaid data and population-based survey data including National Health Interview Survey (NHIS), National Health and Nutrition Examination Survey (NHANES), SEER-linked Medical Health Outcomes Survey (SEER-MHOS).• Wrote protocols, designed CRF and questionnaires, completed sample size and power calculations, wrote grant and IRB methodology sections, created tables and figures for publication, interpreted and presented analysis results for manuscript and abstract development.• Utilized SAS, SAS/UNIX and STATA for descriptive and analytic procedures including regression, survival analyses, multilevel and longitudinal modeling, complex survey analyses and others.

• Managed multiple clinical research studies from site initiation through patient recruitment, sample collection, data collection and reporting.• Provided expertise to PIs for design of clinical research protocols; carried out statistical analyses; assisted with grant writing and manuscript preparation for multiple PI-initiated studies.• Developed data management procedures including database development, data entry protocols and database maintenance for multiple studies.

•Provided technical, operational and strategic direction to humanitarian malaria control programs in several countries; managed all program administrative, financial, logistical and security activities and supervised teams up to 40 people.•Designed and implemented data management tools including questionnaires, databases, entry protocols, quality control procedures and analysis protocols for clinical data.•Coordinated and carried out clinical training and technical support activities in multiple health facilities to improve clinician malaria case management and epidemiological surveillance skills.•Developed, implemented and supervised health education programs aimed at improving treatment seeking and malaria prevention behaviors in target populations.•Produced technical reports for donors and government officials detailing progress against objectives including malaria incidence reduction and quality of care targets; wrote funding proposals for various humanitarian donors.

•Developed and taught innovative new chemistry and biology curricula at Greensboro’s most prestigious private school. •Performance reviews consistently cited ability to effectively convey complex scientific concepts to a variety of learning levels and styles.•One of five teachers in the state selected to participate in exchange program in Africa.•One of four teachers in the United States to win a national competition for curriculum design.•Achieved top honor out of 75 faculty members for promoting environmental awareness.

•One of 25 teachers recruited from Canada for international exchange program.•Developed and taught science curriculum.

•Provided technical direction for HIV testing and molecular biology research laboratory.•Established new laboratory facilities, including selecting, sourcing, procuring and shipping appropriate equipment and supplies. •Supervised and trained clinical laboratory staff in complex technical procedures and concepts.•Developed and implemented new laboratory quality control procedures, SOPs, safety guidelines, consumables inventory control system and training programs.•Organized logistics of field staff and clinics to ensure sample and reporting quality control.