Mike Giunta Email & Phone Number

• Applied knowledge of statistics to fulfil primary duties• Performed statistical consultations as needed for protocol designs (e.g. sample size calculations)• Reviewed statistical analysis section of protocols and data preparing documents• Wrote statistical analysis plans including detailing statistical methods and designing TLG formats• Provided statistical consultations to clients. • Interacted in a professional manner with clients including attending all team meetings as required• Provided statistical support as an active team member for all assigned projects• Ensured the quality of all statistical findings generated for clients• Worked closely with project medical writers to ensure that findings are correctly reported• Maintained detailed records of time spent on each project to allow accurate billing• Respected and maintained the confidentiality of the processed material and ensured that regulations concerning security and confidentiality are complied with• Created specifications for analysis files and derived files• Performed quality control of TLGs and derived data sets created by other statisticians or SAS programmers

Durham, Nc, Us

Develop and implement statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Participate in the project specific programming of statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with GCP and SOPs set forth by PharPoint Research, Inc. and its sponsor clients. Responsible for administrative supervision of interns.

As a Lead Statistician for multiple compounds and indications, works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for protocol development, statistical data analysis, and reporting. •Provide statistical input to clinical development plans;•Cooperate with regulatory staff, medical monitors, clinical scientists, toxicity scientists, and drug safety and public health (DSPH) staff to prepare regulatory submissions;•Cooperate with other internal functional areas to prepare study protocols, clinical study reports (CSRs), investigator brochures (IBs), professional conference presentations and abstracts, presentations for alliance meetings for Phase I/ II/ III studies;•Prepare sample size and power calculation, randomization schedule, kit schedule, statistical analysis plan (SAP), and programming spec; •Direct internal and external teams across multifunctional project areas, leads initiatives to gather, organize, and analyze data from different sources, including the generation of tables/listings/figures (TLFs) based on PK/PD, safety, and efficacy data for planned final analyses, unplanned interim analyses, and ad-hocs; •Prepare DMC charters, organize DMC meetings, and direct the performance of statistical analyses;•Oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for various compounds and indications through management of internal and external resources;•Work with management and Human Resources to satisfy short-term staffing needs;•Lead a specific component of a departmental strategic initiative.

Master Of Science (Ms), Biostatistics

Bachelor Of Science (Bs), Pharmaceutical Sciences