SUMMARY:

• A Total 8 years of experience including 2+ years of SAS Clinical programming in Pharmaceutical Industry using BASE SAS and other SAS procedures and 6 years into Research and Development (Vaccine Production).
• Clinical research experience includes knowledge of all phases of clinical trials, define, analyze, design, development and implementation of statistical data models, writing macros, production of reports, tables, graphs, and listings of clinical data.
• Worked with Statisticians in analyzing the Clinical Trial Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines.
• Experience in developing Macros using SAS procedures.
• Generated reports using PROC REPORT, DATA NULL and PROC TABULATE for customized report writing.
• Experience in developing, validating and implementing SAS programs and produce derived datasets for analysis and generating & documenting tables, listings and graphs for clinical study reports.
• Experience with PROC SQL, PROC DATASETS, PROC FORMAT, PROC PRINT, PROC APPEND, PROC TABULATE, PROC GPLOT, PROC GCHART, PROC COMPARE, PROC IMPORT, PROC EXPORT.
• Experience with PROC TRANSPOSE, SAS/STAT procedures such as PROC FREQ, PROC MEANS.
• Experience in PROC SQL joins and PROC SQL set operators to combine tables horizontally and vertically.
• Used company Confidential .
• Experience in producing RTF, PDF, and HTML files using SAS ODS.
• Good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA.
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM) and Case Report Tabulation Data Definition Specification (Define.xml).
• Excellent communication, interpersonal skills with strong analytical and problem solving skills. Ability to learn quickly and take up new tasks and responsibilities. Can work effectively in cross - functional team environments.
• Good team player with excellent technical and interpersonal skills. Pro-active, self-motivated and able to work independently as well as in team.
• Proficient in creating analysis data sets with CDISC and SDTM standards.
• Created SAS data sets and generated listings, Analysis Data Sets(ADS), graphs and tables (TLG) as per Statistical Analysis Plan (SAP), also performed validation of the CDISC Models.

TECHNICAL SKILLS:

SAS Tools : SAS V9, SAS/Enterprise Guide, SASV9, SAS/BASE, SAS/SQL, Oracle-SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/Reports.

Languages: SAS, SQL, Unix Shell Scripting.

Operating Systems: Windows 2007/2008/XP, UNIX.

PROFESSIONAL EXPERIENCE:

Confidential, St. Louis, MO

Clinical SAS programmer

Responsibilities:

• Performed Data and Statistical analysis using SAS Tools - SAS/Base, SAS/Macros and SAS/SQL.
• Involved with Data management for data cleaning and other data issues.
• Actively participated in several CRF review meetings and vendor meetings.
• Created various SDTM datasets (AE, EX, DS, LB, CM, DM, VS, IE etc.) from raw datasets.
• Created Analysis Datasets from SDTM as per specifications.
• Involved in creating various Safety tables (Summary of Demographics, Adverse Events, Maximum severity grade, Lab-Shift tables etc.)
• Worked mainly in phase I II and III studies.
• Created various efficacy datasets and tables.
• Performed QC validations for various SDTM and Analysis (ADaM) datasets in addition to TLG’s.
• Worked extensively with data management team in PK data analysis.
• Developed several study specific macros, and implemented several macro debugging options.
• Converted various SAS data files into transport files (.xpt) using Proc copy for define.pdf documentation.
• Produced quality customized reports by using Proc report and SAS/ODS.

Confidential, Detroit, MI

Clinical SAS Programmer

Responsibilities:

• Involved in programming, analysis and manipulation of data for Phase II and III clinical trials.
• Reviewed Protocol, CRF, and SAP for creating Analysis datasets, Tables, Listings and Graph’s.
• Analyzed data variables using different SAS procedures like PROC FREQ, PROC MEANS etc. Created SAS views from Oracle database using SAS/ACCESS.
• Used SAS/EG in multi-user environment for intermediate data manipulation, analysis and summary statistics.
• Interacted with data management personnel as necessary to ensure that datasets are in usable format
• Worked with clinicians in study design and result interpretation.
• Generated ad-hoc listings depending on request of client.
• Developed standard Macros and also used existing macros according to the requirements.
• Designed and validated new and existing programs using Proc Compare and Proc Freq depending on the requirements.
• Used Output Delivery System to produce PDF and RTF reports.
• Involved in programming of FDA submission deliverables like Integrated Summary of Safety (ISS) and Efficacy (ISE).
• Involved in reviewing define.pdf, converting SAS datasets to transport files as a part of E-submissions.
• Used PROC SQL coding concomitant medications data with WHO drug and medical history data was coded based on MedDRA.

Confidential

Jr. Research Scientist

Responsibilities:

• Upstream Process development - Media preparation, sterilization, techniques Biochemical tests, Mammalian cell culture.
• Identification and isolation of pure cultures
• Cell line Maintenance and Preservation (BHK-21, Vero, Stem cell)
• Centrifugation, Cell concentration, cell viability via trypan blue dye exclusion, MTT Assay
• Downstream process activities- Paper chromatography, affinity chromatography, size exclusion chromatography, Sterile filtration
• Immunological Technique- Immunodiffusion - AGID, SRID, heamagglutination Assay
• Handling of DNA Samples- Isolation of Genomic and Plasmid DNA, Spectrophotometric estimation, DNA, RNA Extraction
• Techniques in Molecular Biology- Agarose gel electrophoresis, DNA recovery from Gel, PCR Amplification
• Proteomic technique- Protein Analysis via SDS-PAGE
• Titre improvement, working knowledge of different routes administration of formulations i.e IV, SC, IP, PO and Potency testing in guinea pig.
• Arranging periodic calibration of test equipment in the Laboratory either internally or by adequately qualified personnel/ agencies in coordination with Maintenance & Materials Department.
• Managing routine maintenance and up keeping of the analytical equipment on a regular basis for higher productivity and efficiency.
• Ensuring compliance of various quality measures by maintaining requisite documentation/ records. Preparing daily & periodic laboratory reports for information, compliance & corrective action.
• Writing/reviewing detailed documents like SOPs, process and validation protocols.
• Maintaining Monthly Reports, Annual Reports etc.

Confidential

Research Associate

Responsibilities:

• Register, and Generate Bar codes for the clients for Cord blood banking
• Process and Cryopreserve stem cells from Umbilical Cord blood, Cord tissue and Dental Source
• Isolation, characterization and expansion of Mesenchyme Stem Cells for therapeutic application in various medical condition like Muscular Dystrophy, Autism, Cerebral Palsy, Perivascularitis etc.
• Media Preparation and stock maintenance.
• Formulation of dosages for therapeutic application of Stem Cells for variety of diseases.
• Worked on “Training Course module on Adult Stem cells”