Michael Burak Email & Phone Number

Saint Paul, Mn, Us

Minneapolis, Minnesota, Us

• Consulting work with CRO's, independent consultants, and biotech clients• Create and review CDISC SDTM and ADaM datasets, aCRF, Define XML, and Reviewer’s Guide for past and ongoing clinical trials needed for FDA submissions• Provide ad hoc and planned CSR Tables, Figures, and Listings (TFLs)• Able to provide many statistical and SAS® programming services depending on the client’s needs

• Worked onsite in the San Diego office for 1 year and for almost 2 years I worked as a remote full-time SAS® programmer from my home in Minnesota• Worked on a successful Biologics License Application (BLA) eCTD submission for Ruconest® (drug was approved by the FDA)• Worked on a successful New Drug Application (NDA) eCTD submission for Uceris® (drug was approved by the FDA)• I combined pooled Phase III study data for Uceris® to create sponsor-defined SAS® analysis datasets and tables for the Integrated Summary of Efficacy (ISE)• I combined pooled Phase I, II, and III study data for Uceris® to create sponsor-defined SAS® analysis datasets and tables for the Integrated Summary of Safety (ISS)• Provided many analyses for FDA questions regarding Uceris® and Ruconest®• Provided many post hoc analyses in preparation for potential FDA Advisory Committee Meetings for Uceris® and Ruconest® (meeting for Uceris® never took place)• 1 week of Electronic Common Technical Document (eCTD) training which helped with NDA and BLA submissions• Provided ad and post hoc Tables, Figures, and Listings (TFLs) for various types of efficacy, safety and demographic analyses for 4 different therapeutic compounds used in posters, publications, manuscripts, safety reviews, etc.• Created draft post hoc TFL mock shells for Statisticians and other teams to review• Created over 150 TFLs for a Uceris® Signal Detection project for Pharmacovigilance team• Write/Update SOPs, WIs, and Forms• QC TFLs and SAS® datasets provided from CROs• Write & modify various types of template SAS® programs/macros• Assign and monitor work with SAS® programming contractors• Determine edit checks and provide queries prior to locking databases• Review and provide comments for Statistical Analysis Plans (SAPs)

La Jolla, Ca, Us

• Participated and provided many post hoc analyses in preparation for FDA Advisory Committee Meeting for Contrave® (drug was approved by the FDA)• Created post hoc Tables, Figures, and Listings (TFLs) for various types of efficacy, safety and demographic analyses (primarily Phase III ISS, ISE, and individual studies)• Modify ADaM SAS® datasets from other ADaM, CDISC SDTM, or raw eDC datasets• Created primary output and QC of TFLs and SAS® datasets• Write & modify various types of template SAS® programs/macros• Developed SAS® programs/macros that produced Patient Graphical Profiles for AEs, Con Meds, and PK/PD parameters. Outputs ranged from 4-16 unique figures per page and 1 page per patient• Helped developed a process for tracking the company’s various ad and post hoc requests• Developed a SAS® program to output post hoc TOC spreadsheet with hyperlinks for TFLs• Worked closely with the Statisticians to help them develop mock TFLs shells and explain analysis/data related issues to them• Developed SAS® programs for narrative listings for SAEs and reasons for discontinuation• Write/Update SOPs, WIs, and Forms• Initiated a process that would convert raw eDC data – CDISC SDTM – ADaM datasets

• Oversee and manage the Clinical Programming team (SAS® Programming)• 4 workers directly reported to me• Participated in a 3-month in-house management training course• I also continued working as a Statistician• Worked closely with the Data Management, Statistics, Medical Writing, Protocol Writing, Publishing, Clinical, IT, Finance, Operations, and Validation departments within Cetero Research• Worked closely with Sponsors, Vendors, and Contractors to provide them their needs• Write & validate various types of template SAS® programs/macros for Clinical Programming, Statistics, and Data Management within Cetero Research• Write/Update SOPs, WIs, and Forms• Create TFLs for various types of demographic and safety data (AEs, Vital Signs, ECGs, Labs, Physical Examinations, Medication History, Concomitant Meds, etc.) for the CSR• Create in-text and post-text TFLs for various types of analyses within the CSR• Provide CDISC SDTM, ADaM, and sponsor-defined SAS® datasets• Create define.xml or other sponsor-defined SAS® dataset definition documents• QC most of my team’s tasks (SAS® datasets, TFLs, SAS® programs, etc.)• Review annotated Case Report Forms (aCRFs)• Write Statistical Analysis Plans (SAPs) and help Statisticians with complex projects• Assisted Data Managers with building eDC databases

Fargo, Nd, Us

• Write & validate various types of template SAS® programs/macros for the Statistics team• Analyzed many different types of pivotal & pilot BA/BE study designs• Pharmacokinetic designs for Phase I clinical trials• Developed SAS® programs/macros that calculated over 40 PK parameters so that it would replace the need of WinNonlin for PK pivotal & pilot BA/BE study designs• Analyzed many different types of Dermatology Adhesion and Irritation study designs• Analyzed many in-vivo vasoconstrictor study designs (dose ranging, multiple treatment comparisons, BE pivotal, and potency ranking) • Generate various types of randomization schemes• Sample size calculations• Writing Statistical Analysis Plans (SAP)• Write/Update SOPs, WIs, and Forms• Write/Review Statistical sections of CSR and stand alone Statistical reports• Write/Review Statistical sections of protocols

Master’S Degree, Applied Statistics

Bachelor'S Degree, Sport And Recreation Management