SUMMARY

• Over 9+years of experience in Pharmaceuticals and Clinical Research Organization as SAS Programmer wif an ability to work on own initiative as part of a team and motivating team to achieve teh objectives. Dedicated to maintain high quality standards and handling new processes.
• Base SAS Certified and has around 9 years of extensive experience as SAS programmer, SAS Analyst in Pharmaceutical Industries.
• Extensive experience in Statistical Analysis, Reporting and Clinical Data Management involving analysis, design, development, testing and validating teh applications.
• Thorough experience of CDISC and SDTM process. Prepared SDTM and ADaM data sets as per CDISC standards. Used SDTM (v3.1.2).
• Created SAS data sets and generated reports, listings and tables (TLF) as per Statistical Analysis Plan (SAP), Standard Operating Procedures (SOP), also performed validation of teh datasets.
• Experience in handling complex processes using SAS/BASE, SAS/MACROS, SAS /SQL, S SAS/STAT, SAS/ODS, SAS/ACCESS.
• Creating new SAS programs using SAS MACRO to improve ease and speed of modifications as well as consistency of results.
• Proficient in importing or extracting data by connecting SAS System to database systems such as Microsoft SQL, Oracle, Excel, flat files and exporting data to generate dynamic reports in HTML, RTF, XML, Excel, and PDF formats by using SAS/ODS.
• Programming experience wif procedures like PROC DATASETS, PROC PRINT, PROC APPEND, PROC GPLOT, PROC GCHART, PROC COMPARE, PROC IMPORT, PROC EXPORT, PROC FORMAT, and PROC COPY.
• Expertise in using SAS report generating procedures like PROC REPORT, PROC SQL, PROC TABULATE, PROC TRANSPOSE, PROC SUMMARY and optimized performance using data validation and cleaning on clinical trial data using statistical procedures like PROC FREQ, PROC ANOVA, PROC MEANS, and PROC UNIVARIATE.
• Hands on experience in data management like merging, concatenating, interleaving SAS datasets using MERGE and SET statements in DATA step and PROC SQL.

TECHNICAL SKILLS

SAS Tools: 9.1, 9.2, 9.3 Base SAS, SAS/STAT, SAS/SQL, SAS/ACCESS, SAS/ODS.

Operating System: Windows, UNIX.

PROFESSIONAL EXPERIENCE

Confidential, Durham, NC

Statistical Programmer 11 (SDTM)

Responsibilities:

• Base SAS certified programmer, wif around 7 years of experience in teh analysis, implementation and validation of data in Clinical organizations, which includes around six years of experience in SAS programming.
• Experience in SAS/BASE, SAS/SQL, SAS/ODS.
• Created new datasets from raw data files and modified existing datasets using Set, Merge, Sort, Update, and conditional statements.
• Experience in creating Analysis Data Sets (ADS), Tables, Listings and Figures (TLF) as per teh Statistical Analysis Plan.
• Experience in creating CDISC standard SDTM datasets and ADaM datasets.
• QC Programming for Derived datasets, Tables, Listings.
• Programming of Offline and PD Listings.
• Exposure to CDISC Standards.
• Experience in therapeutic areas like Diabetes, Respiratory, Gynecology, Neurology (Bone, Multiple sclerosis) and Orthopedics.
• Developed automation programs for internal purpose.
• Knowledge of complete new drug & device release process from IND submission to FDA approval, which includes Clinical Trials (Phases me - III), preparation of IND, NDA, safety reviews, adverse event report reviews, risk factor.
• Solid understanding of all phases (phase-me to phase-IV) of clinical and pre-clinical research.
• Knowledge of FDA/ICH guidelines.
• A good team player wif strong ability to learn, adapt new skills and make efforts to work effectively.
• Handling team for on time quality deliverables.
• Peer Review of datasets & TFL outputs for all type of sponsor deliverables.
• Advising team members in teh status of schedules and deliverables.
• Currently working as a primary programmer for three studies (BMS) to ensure deliverables of SDTM backend activities on timely manner.
• SAS programming for listings& transfers.
• Bookmarking (aCRF).
• SDTM programming.
• Annotate aCRF to SDTM standards and create SDTMcompliantmapping specification (DTMS) and SAS datasets.
• Creation of vendor data transfer agreement (DTA) for handling third party vendor data.
• Development of define.xml version 2.0 from pinnacle tool and SDRG.
• Transformation of teh data from legacy standard to any client specified standard, mostly
• CDISC compliant.
• Perform Functional quality check of SDTM and SAS datasets.
• Provide training for cross-functional team members regarding EDC systems and various Specifications and day to day processes.
• Proficient in understanding of Study Protocol, Design document, SAP (Statistical Analysis Plan), and CRF (Case report Form).
• Review programs as per good programming specifications.
• Used SAS ODS to produce HTML, PDF and RTF format files.
• Was involved in validation of tables, listings and datasets using procedures like PROC COMPARE and PROC FREQ.

Confidential, Durham, NC

Statistical Programmer 1 (SDTM)

Responsibilities:

• Review Protocol, SAP and CRF.
• Provide technical expertise and resource for teh conduct of eCRF specification Development (RAVE).
• Validating SAS programs as per client assignment specifications.
• Interacting regularly wif clients through teleconference, videoconferences, and e-mails to provide them wif status updates, clarifications, or suggestions.
• Create Ad hoc reports if necessary.
• Reading and understanding teh program specifications document.
• Review SDTM data and provide comments.
• Provide data validation checks for new CRFs.
• Functional and technical testing of teh Database (UAT).
• Test data creation and entry for programming.
• Specification development, as well as mapping specifications to support CDISC standards.
• Functional QC of SDTM datasets, Review SDTM data and provide comments to CRO’s.
• Creation of test scripts.
• E-Data / Vendor mapping specifications creation.
• Participation in sponsor audits.
• Provide training / consultation to junior staff, cross-function team members regarding EDC systems and various specifications.

Confidential

Research Associate

Responsibilities:

• Reading data from excel to SAS environment and create SAS datasets.
• Preparing SAS datasets, tables, listings and reports.
• Analyze teh blood samples using SAS to test efficacy of Antibody sheets.
• Performing Molecular techniques like Purification of DNA from blood, PCR Analysis, Isothermal PCR Analysis.
• Accountable for undertaking assignments in research & managing analytical method development support for teh study.
• Responsible for handling carrying out research and data collection; conducting analysis to determine client’s technical and strategic needs.
• Analyze, summarize and present results for all research projects. Regularly review ongoing research for trends.
• Entrusted wif overall responsibility to manage quality control function to realize zero rejection benchmark.
• Defining quality systems, procedures & work schedules and ensuring strict compliance thereof.
• Performing teh proficiency panel testing on samples. Responding to all queried pertaining to QC testing.
• Implementing preventive and corrective quality control measures to achieve adherence to quality specifications.
• Spruced up QC premises to be ready for regulatory inspections.
• Supervising teh process of manufacturing of Rapid Diagnostic Test (RDT) kits by following cGMP regulations.
• Establishing priorities, monitoring supervisors, trouble - shooting.
• Monitoring teh Quality control (QC) and Quality Assurance processes (QA) like IQC (Internal Quality control) and EQA (External Quality Assessment) for test kits by conducting quality tests and Stability tests wif Known positive samples for Test kits and approving teh test kits by following GLP (Good Laboratory Practice) and Quality System Regulations (QSR).
• Identifying issues and forming hypotheses, formulating and implementing recommendations/solutions.
• Instrumental in preparing Specifications, Technical summary reports, validation summary reports, analytic data review.
• Coordination wif Documentation cell, Quality control for resolving any concerned Issues.

Confidential

Junior Executive Quality Assurance

Responsibilities:

• Preparation and control of SOPs for GMP compliance.
• Preparation and review of Master BMR’s and BPR’s.
• Review of Master Formula Records.
• Standard Testing Procedures & General Testing.
• Monitoring IPQA activities such as checking friability, disintegration time, leak test, tapping or sticking of tablets etc.