Summary:

• Over 6 years of experience in Software development, analysis, design and statistical tools including SAS Software.
• Finely tuned analytical, data management and research skills with dedication to clear communication and presentations. Adept at maintaining an exceptional rate of productivity, accuracy and efficiency; well organized, result oriented and proficient with details.
• Experience working in both Pharmaceutical and Financial firms.
• Have experience in both Clinical Trials and Sales and Marketing in Pharamceutical Industry.
• Sound knowledge in reviewing protocols, reviewing adverse events and doing analysis related to drug safety and patient safety, Analysis of human pharmacokinetic data, allocation in Randomized clinical design, design and analysis of dose ranging studies drug development, PK/PD programming ,SDTM, ADAM standards, E-submissions, transport files, Patient profiles, TLG’s ,Analysis datasets in clinical trials.
• Thorough knowledge in preparing Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21CFR Part 11, FDA regulatory guidelines.
• Sound knowledge related to sales and marketing techniques in Pharmaceutical industry.
• Sound knowledge of Software development like cycle.
• Worked on Development, Testing, Production and Analysis areas.

TECHNICAL SKILLS:

SAS Software\\ Operating system\\
SAS/Base, SAS/Macros, \\ WIN 95/98/NT/2000, UNIX\\
SAS/Assist, SQL, SAS/EIS, \\
SAS/Graph, SAS/Connect, \\
SAS/ETS, SAS/STAT, \\
SAS/share, SAS/OR\\, ODBC,\\
IntrNet

Languages\\ Simulation Software\\
VC++, Mat lab, SQL, \\ Arena, Simulink\\
basic shell scripting\\

AWARDS:

• Best Paper Award in Statistics and Pharmacokinetics Section

Professional Experience:

Confidential Feb09-till date 
Florham Park, NJ and East Hanover, NJ
SAS Developer
Roles: Oncology Business Analysis, Data Management and Clinical Trials Reporting

Responsibilities related to Clinical Trials:

• Provided inputs and worked on CRF design, CRF annotation, Database structure, edit checks, SDTM and ADAM implementations and Integrated database.
• Worked towards drug discovery and design and analysis of dose ranging studies and allocation in the randomized design.
• Created transport files and data mappings.
• Implemented departmental standard report templates.
• Involved in reviewing protocols, SAPs, CRFs, CSRs ,SOPs and review of serious adverse events.
• Worked on analysis for drug safety like root cause analysis.
• Worked on dose ranging and randomized clinical trials relate to cancer research.
• Created programs related to data entry, data management , data validation, statistical report generation.
• Worked on data manipulation of existing data with respect to SDTM standards , and created SDTM specifications for the new data.
• Worked on PK/PD applications.
• Worked on creating TLG’s and analysis with respect to. Safety and efficacy data.
• Good understanding of FDA submissions and 21CFR PART11.

Responsibilities Related to Marketing:

• Created an automated system for the weekly and monthly production process of the oncology products namely: Afinitor, Exjade, Tasigna, Zometa, Proleukin.
• Worked on doing modeling to find out new markets. Worked on regression models and clustering procedures for modeling.
• Worked on customer/physicians segmentation and predictive modeling related to physicians and customer level data analysis.
• Involved in market segmentation, sample optimization and prescription data reports and analysis.
• Involved in promotion response modeling and analysis.
• Worked 40% on development side creating production processes for different products, 30% on the testing side related to test and modify previously created codes and 30% on analysis and adhoc requests.
• Compile and analyze results from marketing campaigns and tests and make recommendations.
• Performed data mining to find patterns in the data.
• Continuous modeling of the product portfolio to track changes in market activity.
• Worked on IMS data and other data providers e.g. Accredo,ASD, and standardizing the data of the various data providers.
• Worked on the Budgeting of various events e.g. Speaker events, lunch and learns.
• Worked on calls data and analysis involving reach and frequency.
• Worked on aligning the data w.r.t various quarters, analyzing sales force/field force effectiveness
• Comparing sales w.r.t to competitor’s drug.
• Worked on analyzing data at various hierarchy
• Tracking doctors moving from one zip to another .
• Worked on adhoc analysis related to sales force effectiveness, Compliance and Persistence analysis.
• Created Web reports using SAS/IntrNet.

Environment: SAS/BASE, Macros on Windows and Unix AIX, SAS Base, Macros, IntrNet, SQL,Oracle, SQL server

Confidential Oct 08 – Jan09

Blue Bell, PA 
Statistical Analyst
Roles: Pharmaceutical Sales Marketing and Business Intelligence Solutions

Responsibilities:

• Worked on Rx data (IMS DDD and CATALINA RX DATA) involved in Patient level and Chain Evaluations of drugs at various chains (Walgreen’s, Rite Aid etc).
• Involved in developing in depth understanding of project/client needs, technical specifications and pharmaceutical data.
• Worked on doing analysis to find out Doctors which are prescribing drugs in particular zip codes and their performance.
• Behavior of doctors in prescribing drug in question to the competitor’s drug, performance of field representatives.
• Analyzing sales force effectiveness, brand performance management.
• Involved in doing Compliance, Adherence, Own User and Acquisition Analysis.
• Customer level data analysis and segmentation.
• Worked closely with Business Analyst on various business requirements and adoption of business course for solutions.
• Analyzing large amount of data and suggesting business courses based on data.
• Worked on Swim lane diagrams related to order processing and fulfillment.
• Involved in assigning Test and Control centers and evaluating rise in ROI in Test centers.
• Worked on creating test and control models.
• Analyzing data on weekly and monthly basis for evaluating volume sales in various chains message printing in test and control sites.
• Involved in analysis related to volume sales of drugs in different zip codes, finding the patients adhering to same drug over the period of time or changing to competitor’s drug or to some other meds.
• Involved in database analysis to find out the chain reporting duplicate values with different transaction numbers for a same patient for a particular drug.

Environment: NT environment, BASE\\SAS, SAS\\MACRO, Proc SQL, Ad-hoc analysis and reporting, Oracle, Natezaa

Confidential Aug 07 – Aug 08
Canton, MI
Clinical SAS Developer
Roles: Data Management CDISC SDTM Implementation, CDMS, Mapping, analysis datasets & E-Submissions

Responsibilities:

• Worked on project of Chicago Based Company Ovation Pharmaceuticals, and worked on their 2 drugs which are in their pipeline related to anxiety and Epilepsy.
• Reviewing adverse events and Worked on drug safety/patient safety doing root cause analysis.
• Project management of Business requirement related to data management and Submissions.
• Worked on requirement analysis creating work breakdown structure and project scheduling of various tasks using Microsoft Project.
• Worked towards MAPPING Corporate data standards to CDISC SDTM STANDARD.
• Worked on CDMS, SDTM mapping, E-Submissions, data validation, data collection Methods, Data Comparisons methods and CRF Annotations.
• Standardized the data into Special purpose domains, Interventions, Events, Findings and Trial design domains of SDTM standards.
• Created an Automated system using SAS for generating CDISC SDTM DATASETS AND THEIR VALIDATION, TRANSPORT FILES, DATA DEFINATION FILES (define.pdf/define.xml), TABLE OF CONTENTS AS DEFINED BY CDISC STANDARDS (Submission Ready).
• Wrote macros for electronic submission (eSUB) of SAS datasets as per guidance and 21CFR Part 11 regulations. Complied with the FDA requirement that SAS datasets submitted are in version 5-transport format (open format published by SAS).
• Created another automated system for the PATIENT PROFILES.
• Created INTEGRATED DATABASE of the SAFETY & EFFICACY DATA.
• Worked towards creating CDISC ADAM datasets and flagging predefined conditions.
• Creating analysis datasets with respect to the Statistical analysis plan.
• Helped on setting specifications of analysis datasets, pooled datasets, statistical summaries, tables and listings.
• Generated XML datasets and style sheets.
• Worked on Oracle and MedDRA.
• Regular interaction with SAS Programmers in US and India Offices.
• PK/PD programming.
• Worked on Oracle Clinical.
• Planned team work assignments and schedules, while guiding and monitoring work performance.
• Created Swim lane diagrams for process flow, activity and milestone charts for checking weekly deadlines.
• Extensively worked on validations checks, developing prototype systems and system testing.
• Extensively worked on documentation of Quality checks of Programs and Logs. Document program sequences showing tasks performed.

Environment: UNIX, SAS Base, Macros, XML, submissions, reporting, data management, SDTM, ADAM, ODM. Oracle clinical, Oracle

Confidential Nov06 – July 07
Little Rock, AK
Clinical SAS Programmer
Departments: Clinical Trials Reporting.

Responsibilities:

• Create define and transport files for NDA submission - CDISC (SDTM, ADAM, ODM ISS / ISE programming in NT environment.
• SAS graph programming.
• Data integration and TLG programming.
• Ad-hoc reporting of weekly and monthly requests.
• Strong ODS programming experience.
• Assist with study level data and documentation preparation for submission, following FDA guidelines.
• Provide programming support to e-submission team Work as a member of the submission readiness team, organize, review and update, if necessary, the internal documentation for each study to make sure it follows the appropriate protocols.
• Creating electronic data sets (i.e. SAS transport files) for electronic submission using Proc XCOPY as per 21 CFR Part 11.
• Developed standard reports for Safety & Efficacy data including laboratory and adverse event summaries for IND (Investigational New Drug).
• Annotating CRF with database formats and Programming Edit Checks to support clean file efforts. Validation/Verification process in compliance with regulations and policies by creating Constraints.
• Prepare the data and documentation for each of the 60 studies for transfer to the FDA.
• Experience with clinical data as well as FDA guidelines and requirements for NDA, as well as experience in assembling programming documentation for an NDA.

Environment: Windows, UNIX, SAS Base, Macros, SQL, Access, Oracle, Teradata, SDTM, ADAM, ODM

Confidential March 06 – Nov06
Buffalo, NY
Statistical SAS Programmer 
Department: Clinical Trials

Responsibilities:

• Validation of input character data using Proc FREQ and numeric data using Proc UNIVARIATE
• Creating data definition tables for electronic submission.
• Development of standards that improve efficiency while supporting scientific nature of clinical research using CDISC.
• Generate Aggregate Reports (PSUR, ASR, QSR, IND, and NDA).
• Produced various reports such as ASR, PSUR, Signaling, etc. as per various database instances for marketed and investigational drug products.
• Followed and adapted the best practices pertaining to GDP, GCP and various SOP and Protocol standards.
• Read/Develop Protocols and understand relationships of data being captured from a programming perspective.
• Involved in review of protocol, case report forms (CRF). Also responsible for edit checks of clinical trials data to identify illogical data entries.
• Creating electronic data sets (i.e. SAS transport files) for electronic submission using Proc XCOPY as per 21 CFR Part 11
• Creating Kaplan-Meier survival curves using Proc LIFETEST, Proc ANNOTATE and Proc GPLOT

Environment: UNIX, SAS Base, Macros, Oracle, Reporting, Adhoc Analysis.

Confidential Aug 05 – March 06
Buffalo, NY
SAS Analyst 
Roles: Risk Analysis

The purpose of CDIT tool is proactively monitor the Data Integrity of key risk systems namely Global Risk Management System, Global new accounts, Credit Authorization Systems, World wide Credit and Collections etc. CDIT encompass twp modules, one to track data sources to global risk management system and the other to track the decision outcomes from the risk core systems.

Responsibilities:

• Design and develop, efficient tool for data integrity tracking.
• Worked towards creating Credit risk models (to find out risk related to investment), Evaluation of portfolios (to determine present value of investments of their customers).
• Ensured accurate and flexible design for CDIT.
• CDIT architecture includes extraction, Profile, Validation and alert phases.
• Understanding various data sources to the GRMS (Global Risk Management System).
• Worked on initial pre screen engine for the customers.
• Worked on creating profiling models on SAS/STS and Enterprise miner.
• Identifying the critical variables to the business.
• Extracting data from Mainframe flat files usingSAS Base and Macros.
• Validating and profiling the variables using SAS Base / Macros using proc freq,proc means, proc format and proc univariate.

Environment: SAS Base, Macros, SQL, PL/SQL, Windows, Unix, Mainframe.

Confidential March 04 – Aug 05
Statistical Analyst 
Roles: Data Management and Reporting

Responsibilities:

• Involved in Business Analysis for requests, documenting the Specifications, programming in SAS.
• Performed review and evaluation of Clinical Research related programs, involving preparation, developing data, analyzing, coding, and analysis,generating reports and testing programs according to the investigator’s requirements.
• Created Summary and cumulative summary reports as (a) First of Breed (b) Re-execution (c) Revamp (changes per specification and business needs).
• Host the Draft Tables review meetings before issue of Final reports to ensure adherence to standards and protocol requirements. Make necessary modifications to the Draft Tables if required based on input from the project team.
• Ensure the quality of the reports through Quality Checks (QC) following various methods such as programming, peer review, code walkthrough using set standards like QC of 100% of the data on 10% of the subjects, depending on the type of data endpoints.
• Developed SAS programs to generate SAS reports, Pharmacy Profiles for providers based on Clinical Trials and Statistical data. Formulation involved random sampling, based on that statistical data is generated which is viewed and reviewed, and based on that formulation reports where generated.
• Annotating CRF with database formats and Programming Edit Checks to support clean file efforts. Validation/Verification process in compliance with regulations and policies by creating Constraints.
• Preparing the statistical summaries and reports, identifying the problems with data if any and producing Value Added Datasets, tables, listings and figures, which is analyzed the data.

Environment: Windows SAS Base, Macros, Graphs

Confidential Jan 04 – March 04
Analyst 
Roles: Reporting

Rail Coach Factory is a Government organization and Asia’s best railway coach manufacturing unit. They make different types of coaches’ sleeper class to air conditioned one. They have a very large number of vendors and a very big supply chain system and all the data about the vendors and their products is stored in a Oracle database.

Environment: Windows, Oracle

EDUCATION:

• Master’s in Industrial Engineering & Statistics from Confidential University
• Bachelors in Industrial Engineering from Confidential University