Ray Staton Email & Phone Number

I work as a Principal Consultant in the Oncology Department at Astrazeneca. My primary responsibilities include SDTM, ADaM, TLs, patient narratives, Immune Mediated Adverse Events of Special Interest

Raleigh-Durham, North Carolina Area

Principally working for a major pharmaceutical company on a pivitol study with time-critical deadlines. Working exclusively with SDTM and ADaM datasets within a highly structured environment.

I am currently working on programming support for HIV and Oncology studies.

I'm currently working on programming support for HIV and Oncology studies.

Served as the IT SME (Subject Matter Expert) for SAS in the PC, Unix and Virtual Machine environments. Was responsible for SAS IQ, OQ and PQ across all platforms. Authored the batch files for automated set init and hotfix rollout to offices of INC Research in the US, UK, Amsterdam and India. Was responsible for tracking SAS licenses for licensing compliance as well as participating in sponsor audits regarding SAS and SAS-related products. Responded to customer audits and performed final audit reviews of validation packages before submission to Quality Assurance. Reviewed all Change Management Plans for changes to computer software or hardware. Served as the SAS Drug Development SME.

Managed a small statistical programming group consisting of in-house programmers as well as remotely-located programmers. Served as a mentor to more junior level programmers. Worked closely with external vendors to handle the day-to-day activities involved in running a large number of studies spanning multi-therapeutic areas. In conjunction with other management staff, was responsible for programming SOPs and compliance. Provided time estimates for the programming components of RFPs. Also participated in bid defenses and qualification audits. Worked closely with biostatistical management to ensure the timely production of high quality TLFs (tables, listings and figures). This task included the review of analysis file specifications from a set of raw data files provided from Oracle Clinical or RDC (Remote Data Capture) software, the programming of analysis files from the reviewed specifications, and updates to the specifications as needed based on actual programming.

Handled the daily responsibilities of managing a small statistical programming and data management shop. Worked closely with CRO vendors, central labs, and IVRS vendors to handle the routine activities involved in running a large number of challenging gastrointestinal studies. Was instrumental in the submission and approval of one NDA submission.

Primary duties consisted of handling the daily statistical programming responsibilities associated with the submission of an NDA as well as programming validation for numerous other gastrointestinal studies. Developed programming SOPs for our group as well as handled the more challenging programming responsibilities. Also mentored our programming and data management staff. Specific hands-on programming tasks during this period of my career consisted of analysis file programming and harmonization across a 12-study database consisting of Phase I, Phase II and 4 large, Phase 3 databases. Was also involved heavily in the review of listing and statistical table shells, and the actual programming of ISS and ISE tables for the submission. Was also responsible for the preparation of the FDA datasets for the submission, bookmarked CRFs, conversion of Excel data files (from PK studies) into SAS datasets, control datasets containing formatting information, and linked PDF Define Documents.

Served as the SAS programming expert for a group of 8 in-house programmers. Worked on complicated utility macros for the department as well as helped the junior level programmers with suggestions on how to solve their routine programming problems. Also served as a consultant to the other programmers in the department on central laboratory related issues. Primary hands-on responsibilities included the production of summary Adverse Event and Concomitant Medication tables as well as the creation of a laboratory analysis dataset combining laboratory data from various local labs (domestic and international). This task included the creation of a combined normal range dataset containing conversion factors for converting reported and conventional units to SI units for harmonization of analysis as well as the programming code for attaching these ranges to the appropriate records in the laboratory analysis dataset based on the laboratory test, sex, age and effective dates.

• Served as the central laboratory processing lead for all of the COVANCE, CRL (Clinical Reference Laboratories), Mayo Central Lab for Clinical Trials, Cardiac Alert and Premier Research Central Labs. Validated all of the file transfers, interacted with the labs to answer questions, did laboratory file revisions, and ensured that the lab files were in the correct form to make analysis easy and efficient. Handled over 60 transfers per month. In addition, handled all of the QLAB (Quintile’s Laboratories) central laboratory data transfers. Worked with every major central lab which the CRO industry uses. Specific hands-on tasks included writing the programs to read laboratory data files in a variety of text file formats and convert them into SAS datasets as well as writing programs to convert the resulting SAS datasets back into text files and doing an electronic comparison to ensure that laboratory data was not being lost during the text file conversion.

Served as the central laboratory processing lead as well as the lead programmer on several major projects for the Quintile’s RTP office. Responsibilities included the handling of laboratory data, file manipulations, table and appendix listing programming, CRF tabulation programming, and support programming for the junior programmers in the department.

Performed all of the analysis programming for the Health Outcome’s section of the Duke University Medical Center. Supported 6 statisticians and several physicians in the processing of health outcome data as well as cost analysis and quality of life data. The majority of my hands-on experience during this phase of my career was involved in writing code to create SAS views from an extremely large and highly complex medical database maintained by Duke University. Much of the programming was related to cost analysis of procedures versus the corresponding improvement in the patient’s quality of life. Also did a great deal of programming using data from Excel spreadsheets and text files. The majority of the reporting was done using DATA _NULL_ programming. Participated heavily in the programming necessary for manuscript submission to prestigious medical journals.

Supervised a staff of 7 moderate to senior level programmers in all aspects of analysis file creation, listing and table generation, CRF tabulation processing, and general technical support. Also supported the data management group in all SAS related tasks involving file manipulation and external file processing.

Supervised a staff of 5 to 7 junior and senior level programmers. Was responsible for training in listings, table and CRF tabulation production. Was the primary support for DBMSCOPY. Authored a SAS system of macros for CRF tabulations. Hands-on experience included all programming tasks related to the production of Appendix listings and statistical tables. Was also heavily involved in preparation and review of programming specifications. During this time in my career, performed a great deal of macro programming. CRF tabulations (or patient profiles) were a large part of submissions at this time, and after having done numerous sets of these profiles, developed a set of macros based on templates and DATA _NULL_ programming to aid in their production. This programming was done in a VAX/VM environment with code development being done in a PC environment. Actual production was done via the VAX.

During this period worked as a Statistical Programmer I and later as a Statistical Programmer II. Created appendix listings, analysis variable files, graphs and tables. Also handled external files (such as data in Excel, ASCII and Paradox).

Taught a variety of computer science courses such as FORTRAN, COBOL, ASSEMBLER and PASCAL for East Carolina University. Also taught a wide range of mathematics courses including Matrix Algebra, Calculus I and II, Advanced Algebra and Trigonometry.

Master'S Degree, Mathematics And German

Activities and Societies: Pi Mu EpsilonI studied Mathematics(Ring Theory) and German literature.

Master Of Arts (M.A.), Mathematics And German

Activities and Societies: Mathmatics and German Honor SocietiesI studied Mathematics(Ring Theory) and German literature.