Data Management Clinical

Sadathullah Syed

Email: adyeog@r.postjobfree.com

Mobile No: 872-***-****

OBJECTIVE

SAS/ Statistical programmer with over 2+ years of experience in data management and statistical programming in various phases of clinical trials working for pharmaceutical companies and Clinical Research Organizations (CRO). Extensive experience in Statistical Analysis, Reporting and Clinical Data Management involving analysis, design, development, testing and validating the applications.

PROFESSIONAL SYNOPSIS

●Excellent ability to read SAS data sets and create variables.

●Excellent knowledge of clinical trial phases, clinical protocols, CRFs, and annotated CRFs.

●Experience P21 validation.

●Developing SDTM Spec and SDTM Domains based on Annotated CRF.

●Generating and Validating Pinnacle Report (OpenCDISC Validator) to check the compliance of final SDTM datasets with SDTM IG standards.

●Experience in generating safety tables such as DM, SV, AE, CM, MH, VS, etc…

●Experience in data mapping from SDTM to ADaM.

●Experience in creating specifications for ADaM (ADSL,ADAE,ADLB,ADVS).

●Extensive knowledge in SAS Products, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ODS, SAS/REPORT.

●Exceptional report-creation abilities with SAS Procedures such as Print, Report, Freq, Transpose, Means, Contents, Formats, and SQL.

●Exporting and importing data from other databases by using PROC IMPORT/EXPORT procedures.

●Generated reports using PROC REPORT, DATA _NULL_ for customized report writing

●Experience in developing, validating, and implementing SAS programs and producing derived datasets for analysis and generating & documenting tables, listings for clinical study reports.

●Good experience in validation of ADaM datasets, Tables, and listings.

●Used ODS to display outputs in HTML, CSV, TXT, or other file formats.

●Missing data handling using LOCF, BOCF concepts and written analysis files specifications for various therapeutic areas.

●Have a good ability to rapidly adapt to new applications and platforms.

●Excellent team player with good analytical and communication abilities.

PROFESSIONAL EXPERIENCE

FL Tech Solution LLC

Statistical Programmer May2021-Present

Project -1

A Phase 1b Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilator Effect in Patients with Chronic Asthma.

Responsibility:-

●Developed SAS programs to perform edit checks on clinical data received from CRO’s and internal data warehouse.

●Performed Data analysis, statistical analysis, generated reports, listings, and graphs using SAS/Base, SAS/Macro and SAS/Graph, SAS/Access, SAS/ODS.

●Analyzed data using SAS Statistical Procedures such as Proc Means, Proc Tabulate, Proc Freq, Proc Summary. Prepared new datasets from raw data files using Import Techniques and modified existing datasets using Data Steps, Set, Merge, Sort, and Update, Formats, Functions, and conditional statements.

●Developed numerous SAS programs to create summaries and listings

●Generated customized reports using the DATA _NULL _ and PROC REPORT.

●Used ODS to create deliverable documents.

●Validated the derived datasets using proc compare and resolving the Errors/Warnings/Notices accordingly.

●Following Client SOP’s and Meeting Deadlines.

TECHNICAL SKILLS

●MS Office : Excel, Access, Word

●SAS Tools : SAS/BASE, SAS/SQL, SAS/MACROS and CDISC( SDTM, ADAM,TLF's)

●Operating System : Windows, Unix

●Database : Oracle, SQL server

ACADEMICS

●Masters Of Business Administration June2009- May 2011

(Osmania University)

CERTIFICATIONS

●SAS Certified Specialist: Base Programming Using SAS 9.4

●Received certification on completion of SAS 9.4 BASE from institute of clinical SAS

●Received certificate on completion of SDTM CDISC ADAMS Standards

DECLARATION

I hereby solemnly declare that all the information provided here is genuine as per the best of my knowledge.

Place : CHICAGO SIGNATURE:

(Sadathullah Syed)

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