Principal statistical programmer

Over ** years of experience analyzing, designing, reporting and implementing various analytical information system and over 12 years of experience in developing and implementing various applications in Pharmaceutical and Clinical Industries.

Extensive experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ODS in Windows and UNIX environments.

Extensively worked on CDARS systems with over 10 years of experience.

Extensively involved in Clinical Data Analysis and preparation of Analysis SAS Datasets, reports, tables, listings, summaries and graphs for Clinical Study Reports in compliance with 21 Code of Federal Regulations (21 CFR) Part 11, FDA, Standard Operating Procedures (SOPs) and departmental guidelines.

Experience in implementing SAS procedures, macros, and applications for data cleaning, reporting, and documentation.

Experience with all phases of Clinical Trials.

Familiarity with electronic submissions and CDISC data standards

Familiar with ICH guidelines and electronic submission standards for FDA.

Experience in data transformations and edit check.

Experience in analyzing the Case Report Forms (CRF) data.

Worked with statisticians in preparation of SAP (statistical Analysis Plan), Table shells and other specifications based on protocol.

Excellent problem-solving ability with strong verbal and written communication skills. Self starter and a motivated team player.

EDUCATION / CERTIFICATIONS

Master’s Degree in City and Regional Planning (M.C.R.P)

University of Memphis - Memphis, TN

Bachelor’s Degree in Civil Engineering (B.Tech)

Kakatiya Institute of Technology and Science– Warangal, India

Certified Base Programmer for SAS 9, 2009.

CDARS certified (Pfizer).

SKILLS

Languages

C, SAS (BASE, STAT, GRAPH, CONNECT, MACRO, ASSIST), SQL

Operating System:

Windows 95/98/NT, UNIX

GUI

Oracle (Forms & Reports)

Statistical Analysis Software

S-PLUS, SPSS

Databases

Oracle 8, Clin Trial (CT4), MS ACCESS, MS EXCEL

Other

AutoCAD, GIS

PROFESSIONAL EXPERIENCE

Pfizer Inc, Collegeville, PA (Remote) Oct ’18 – Till Date

Statistical Programming Lead (Manager)

Pfizer is world's premier biopharmaceutical companies. Its portfolio includes medicines and vaccines to treat various conditions such as cardiovascular, metabolic and pain, women’s health, cancer, inflammation, immune disorders, and rare diseases.

Responsibilities:

Serve as a lead programmer on multiple studies and coordinate all programming aspects of the project in Vaccine Therapeutic area.

Served as a critical team member in the projects related to COVID-19 vaccine.

Works on numerous light speed studies with tight timelines and submission work.

Perform other programming tasks necessary to support Clinical Data Management and Biostatistics.

Interact with the project team leads and sponsor on programming aspects of the project and present at meetings, as required and communicating actively and frequently with other team members as needed.

Provides/leads the programming support for the specification, production and validation of data listings for Data Management, Clinical Operations and the sponsor.

Provides the Project Manager, Biostatistics department and company management with timely, accurate status and resourcing updates.

Contributes to and reviews statistical analysis plans, mainly through table, listing and graph specifications.

Contributes to and reviews results presented in statistical reports, integrated clinical/statistical reports, integrated summaries of safety/efficacy and other documents, as required.

Oversees the Quality Review of the statistical reporting of selected projects. Ensures appropriate project documentation is completed, maintained in an ongoing manner and consistent with company SOPs and working practices.

Mentors’ members of the department, providing project guidance and SAS® programming advice. Allocates and co-ordinate resources within the team to achieve timelines.

Environment: SAS 9.3/9.4, UNIX, MS-Word, MS Excel, Windows, TOAD, ORACLE CLINICAL, CDARS systems (Pfizer).

ICON Clinical Research, North Wales, PA June ’13 – Apr ‘18

Sr. Statistical Programmer I (Remote)

ICON is a global provider of outsourced drug development services to biopharma, medical device, government, biosimilar and generic organisations.

Responsibilities:

Leading Studies for Steering Committee, DMC and Blinded Data Review Deliverables by managing Global teams.

Worked as SME (Subject Matter Expert) related to Client based reporting tools, Integrated Statistical Analysis Modules, Patient Profiles, and modules related to LABS, ECG, VITALS etc.,

Worked extensively on Patient Profiles for numerous complex studies including Adjudication Data.

Provided training to members new to CDARS systems and helped various teams with system/study setup and debug.

Experienced in Datasets creation and table programming for Integrated Summary of Safety (ISS) and Efficacy (ISE).

Worked extensively in creating specs and converting raw datasets to SDTM and ADAM CDISC compliant datasets.

Worked to create reports by successfully co-ordinating teams from different locations.

Developed standard maintainable, supportable, well- documented computer programs that are user-friendly and accessible.

Assisted in the training of programmer analysts and ensures the continued development of data analysis skills.

Provided specifications for Programmers in the development of standard software and data structures.

Extensively used SAS/MACRO facility for debugging and for creating reusable programs.

Excellent work experience in generating reports, tables, listings, and graphs according to Statistical Analysis Plan, Standard Operating Procedures (SOPs) and departmental guidelines.

Worked closely with senior Bio-statisticians in creating dataset specifications, Data presentation plan and adhoc reports.

Worked closely with Client on daily basis to ensure the TLFs generated for delivery are as per expectation.

Always maintained accuracy of all results and appropriate documentation.

Participated in cross-disciplinary teams designing analysis, timelines, and assumptions.

Environment: SAS 9.1/9.2/9.3, UNIX, MS-Word, MS Excel, Windows 2010, CDARS systems (Pfizer).

Inventiv International Pharma Services Private Ltd, Hyderabad, India May’12 – Mar’13

Senior Statistical Programmer

Inventiv Health clinical segment is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, including therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and staffing from a single clinical professional to an entire functional team.

Responsibilities:

Working as lead programmer in developing TFL’s for multiple studies within Diabetic Therapeutic area.

Working as Requirement Writer for high priority studies.

Validate and/or perform quality control checks on Programs related to other Team members.

Working as POC (Point of Contact) for one of the studies for Final DBL.

Communicate and provide feedback to Statisticians regarding data issues and other programming issues during program development process.

Mentored and trained new associates within the Statistical Programming group.

Participate in the creation and maintenance of Statistical Programming project documentation.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/SQL, SDD systems, WINDOWS, UNIX, MS EXCEL.

Quintiles Inc., Overland Park, KS Sep’09 – Apr’12

Statistical Programmer II (Home based)

Quintiles clinical research organization (CRO), CSO, & Consulting services helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Responsible for developing and maintaining programs and performing QC for NONMEM datasets including but not limited to PKPD, POPPK, PKECG, PKBP, and PDAE from Phase I through III with a variety of studies for Pfizer.

Responsibilities:

Responsible for developing and maintaining programs for analysis and presentation of pharmacokinetic and pharmacodynamic data for Clinical Pharmacology reports.

Provide SAS programming and analysis support for Phase I clinical trials in preparation of CSR.

Develop code for PKPD/POPPK/PKECG/PDAE using SAS, validate and QC code and related documentation.

Program the integration of databases from multiple studies or sources.

Develop and plan programming documentation including plans and specifications, as appropriate.

Perform and plan the development, implementation and validation of new process technologies, macros and applications.

Perform and plan the programming of database quality control checks.

Fulfill project responsibilities at the level of statistical team lead for single studies, under supervision.

Understand the Scope of Work, estimate the work completed, and manage Out of Scope for single studies.

Provide training and guidance to lower level and new staff.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/SQL, CDARS systems, TOAD, ORACLE CLINICAL, WINDOWS, UNIX, MS EXCEL.

Sanofi-Aventis - Bridgewater, NJ Jan’06- Jul’09

SAS Programmer (Clinical) - Biostatistics & Programming Dept

Sanofi Aventis, the 3rd largest pharmaceutical company in the world, is involved in developing innovative treatment solutions in therapeutic areas such as psychiatry, cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines. My role as a statistical programmer is to analyze Phase I clinical trial data and generate required reports, listings, summaries and graphs in accordance with the Standard Operating Procedures (SOPs) and guidelines for submission to FDA.

Responsibilities:

Provide SAS programming and analysis support for Phase I clinical trials in preparation of CSR.

Generate statistical analysis files, tables, listings, and graphs according to Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines.

Review DRR with Clinical Data Management (CDM) group and analyze Clinical Trial Data.

Participate in Data Review Meetings to analyze tables and listings generated for the snapshot of clinical trial data at a given point.

Work with bio-statisticians in analyzing PK, PD data and developed SAS Macros for generic coding and reusable modules.

Used statistical procedures: REPORT, CPORT, EXPORT, IMPORT, FREQ, MEANS, UNIVARIATE, MIXED, GPLOT and GCHART.

Perform Edit Checks on unclean data before DBL and report issues to CDM group.

Implement CDISC SDTM and ADaM standards for Statistical summaries and Analysis.

Perform Validation and review DVP as part of QC documentation.

Data extracted from Clin Trial (CT4) and Oracle clinical (OC) databases, performed Data Mapping and created SAS statistical analysis files.

Was part of different review teams in implementation of new standards at various levels of programming.

Provide data in SAS Transport files, and other appropriate deliverables for regulatory submissions.

Develop SAS programs for adhoc reports using ODS.

Perform programming activities as per GPP guidelines.

Perform Safety (ISS) reporting for phase I FDA Drug submissions..

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/SQL, ORACLE, PL/SQL, CLIN TRIAL 4.0, ORACLE CLINICAL, S-PLUS, WINDOWS, UNIX, MS EXCEL.

Comsys (Pfizer Global Research and Development) -Kalamazoo, MI Sep ‘05 – Dec ‘05

Statistical Programmer

Pfizer Inc is the world’s largest research-based pharmaceutical company, discovers, develops, manufactures and markets leading prescription medicines for humans and animals, as well as many of the world's best-known consumer products. Pfizer is consolidating its data collection and reporting standards into a new global standard. As SAS programmer I was involved in Data Mapping of legacy data that was created using various data standards into Pfizer Global data standards.

Responsibilities:

•Create and update Logical Data Maps of different Data Modules for Data Mapping purposes from DSC and CRF data.

•Convert legacy data standards into company’s data standards and produced reports using CDARS system.

•Create/implement SAS macros in accordance with the Logical Data Maps to convert the legacy data into Pfizer Data standards.

•Used procedures like PROC FREQ, PROC SORT, PROC PRINT, PROC TRANSPOSE and PROC SQL.

• Generate reports using ODS.

• Generate listings using SAS to be compared with reports from the PDS reporting system.

• Developed and customized reports using PROC REPORTS, PROC TABULATE PROC SUMMARY and DATA_NULL_.

• Perform Quality Control checks (QC) steps in accordance with the Pfizer mapping Process.

• Validate the SAS Code generated by other Programmers.

• Prepare SDLC documents for Data modules.

Environment: SAS/BASE, SAS/MACRO, ORACLE 8i, PL/SQL, WINDOWS, UNIX, MS EXCEL, SAS/ODS, CDARS systems.

Regional Economic Development Center – Memphis, TN Jan’02-May’05

Graduate Research Assistant

Responsibilities:

Assisted Planners in Data Collection, Analysis and Illustrations.

Collect, maintain and create data for the City’s Geographic Information System (GIS).

Incorporate Utility information into Master Plan using AutoCAD and GIS.

Maintain and update database information.

Prepared Parcel Maps, Land Use Maps, Zoning Maps and Thematic Maps for different Counties and Cities using GIS.

Used various statistical techniques in planning data analyses using SAS, SPSS and other statistical related software’s

Prepared instructional tutorials for students to assist them in learning Auto CAD.

Expert skills in analyzing present trends and forecasting of demographic, socio-economic and market analysis.

Environment: ArcGIS 8.0/9.0, ArcInfo, ArcCatalog, ArcToolbox, WINDOWS, MS EXCEL, AutoCAD, SPSS, SAS.

CONFERENCES:

PHUSE US Connect 2023 - Mar2023 - Presenter

Topic presented: Challenges of Handling Vaccine Serology Data for Analysis and Reporting

AWARDS / HONORS

Won 2022 Craig A. Saxton Clinical Development Excellence Award for COVID-19 Vaccine.

Won multiple ICON Inspire awards (ICON, 2015, 2016, 2017)

Work Worth Doing Award (Quintiles, 2010)

Won multiple Mathematics Merit Scholarships in High School.

Current Status: US Citizen

REFERENCES:

Available upon request.

Contact this candidate