Clinical SAS Programmer

Kuldeepsinh Atodaria [SAS Programmer]

Suit#**, **15, Parliament Avenue, Regina, Saskatchewan, Canada - S4S2L3

Ph no.- +1-306-***-****, Email ID- ***********.********@*****.***

Summary:-

. Strong 3+ years of experience in the pharmaceutical industry working

as a SAS programmer/analyst, FDA Assistant and Medical Representative

expertise on two domains 1. Registration of the drug products in the

different countries as per there Regulatory requirements. 2. Working

in the field to achieve the sales target.

. SAS certified Programmer using SAS for Data Management.

. Experience in preparation of SAS datasets, Tables, Listings, Reports,

Output Delivery System (ODS) and Summaries according to requirements,

Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP).

. Strong experience in Base SAS, SAS/MACROS, SAS/ACCESS, SAS/ODS and

SAS/SQL in Windows environments.

. Excellent knowledge of Medical Terminology and ICH, GCP, CDISC, MedDRA

regulatory Guidelines.

. Proficient in understanding of Study Protocols, SAP (Statistical

analysis plan), and CRF's

. Experience with transforming data in various formats (excel, CSV) into

SAS datasets

. Having excellent command in producing reports employing various SAS

procedures like Proc Print, Proc Report, Proc Mean, Proc Freq, Proc

Transpose, and Data _NULL_.

. Little experience using SAS/GRAPH to produce Graphs by employing SAS

procedures such as Proc Gplot and Proc Gchart.

. Exceptional ability in problem solving, data analysis, complex reports

generation with macro and data transfer between different

environments.

. Experience in cleaning and resolving data issues as well as merging

data from different sources into a single integrated dataset.

. 100% Project completion on time while meeting strict timelines and

budget requirements.

. Quick learner and excellent team player, ability to meet deadlines and

work under pressure.

. Excellent monitoring experience of verifying data in eCRF, eSD for

completeness and consistency according to protocol and regulatory

requirements.

. Used edit check for different studies.

Professional Certification:

. SAS Certified Base Programmer

. SAS Certified Advanced Programmer

Education:

. Master of Pharmacy in Pharmacology

Annamalai University, INDIA.

. Bachelor of Pharmacy

Rajiv Gandhi University of Health Science, INDIA.

Technical skills:

. Statistical Packages: SAS/BASE, SAS/GRAPH, SAS/MACROS,

SAS/ODS,SAS/REPORTS, SAS/ACCESS.

. SAS Procs:- Print, Means, SQL, Report, Freq, Sort, Summary, Format,

Import, Export, Transpose, Compare, Gplot and Gchart.

. Development Tools:-MS Office.

. Operating Systems:-Windows XP/7.

Work Experiences:

Accenture Services Pvt. Ltd., Mumbai, INDIA Aug'11- Jul'13

Role: SAS Programmer

Accenture is a big MNC working for variety of Pharma clients and fulfill

their need as per there requirement . As a SAS programmer, performed

relevant statistical analysis of data captured during clinical trials.

Responsibilities:

. Worked in Phase I, II,III and IV of clinical trials for studies in the

Epilepsy, Rheumatoid Arthritis therapeutic area.

. Performed data validation on the data sets and deleted repeated values

using conditional data steps such as nodupkey, if-then statements.

. Designed statistical tables, graphs, and data listings.

. Developed SAS macros for data cleaning and reporting and to support

routing process

. Performed Data Analysis on the data sets using PROC MEAN, PROC FREQ

and PROC TRANSPOSE, PROC MIXED, ARRAY.

. Developed reports using PROC REPORT and DATA _NULL_.

. Generated output files in text format, HTML & PDF format using SAS

ODS.

Environment: SAS BASE, SAS/SQL, SAS Macro, SAS/ACCESS in Windows.

West Coast Pharmaceuticals Works ltd., Ahemedabad, INDIA Oct'07- Jul'08

Role: FDA Assistant

West-Coast is a manufacturer of Pharmaceutical Formulations mainly Human

and Veterinary use since 1965. West-Coast has a well sophisticated WHO GMP

manufacturing plant.

Responsibilities:

. Collect the Annexure from export department for different Regulatory

to check the documents need.

. Collect the production documents such as BMR (Batch Manufacturing

Report) from the Production department.

. Collect the QC report for all raw materials used as well as final

product and stability report of the final product from QC department.

. Collect WHO, GMP and Product Permission from the QA department.

. Collect packaging material from the packaging department.

. Collate all the documents and prepare dossier as per the Annexure then

it will submit to the Regulatory of different country.

. Resolve the queries of regulatory for the submitted product.

Micro Labs Limited, Ahmedabad, Gujarat, India.

Trainee Territory Executive, Jun'07-Sep'07.

. Meet the doctors & Generate Prescriptions. Meet chemists & do

launching new products, To achieve sales targets as per company

strategy.

Languages Skills

. Familiar with conversational and written English, Hindi and Gujarati.

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