Shruti Sharma

E-mail : ac4qgz@r.postjobfree.com

Cell: +1-669-***-****

SUMMARY

Certified Statistical SAS Base Programmer with overall experience of 5 years in pharmaceutical industry out of which 3 years working with SAS tools emphasizing on analysis, program development, QC and validation.

Extensive experience in various therapeutic areas including Oncology, Cardiovascular disorders Immunology and Endocrinology.

Hands on experience in Phase II and III clinical data: analyzing clinical data, creating tables, listing and generating reports.

Experience in managing SAS data files, merging, using Arrays, SAS Macros, SAS Formats and the Informats.

Experienced in producing reports in varies file types such as HTML, PDF, RTF and EXCEL using SAS/ODS.

Thorough knowledge of various clinical documents such as Protocol, CRF, e-CRF, and SAP.

Knowledge of the clinical study process, CDISC (SDTM), FDA guidelines, GCP/ICH guidelines.

Developed programs to examine the database for inconsistencies, out of range or missing values and thorough knowledge in handling missing data values, implementing LOCF.

Familiarity with FDA regulations, standard operating procedures (SOPs), good programming practices (GPP).

Utilized MedDRA and WHO-DRUG dictionaries in creating summary tables for Adverse Events and Concomitant Medications respectively.

SKILLS

SAS Applications: SAS/BASE, SAS/STAT, SAS/SQL, and MACROs

Statistical package: SAS 9.3, SAS EG, Bio-statistical concepts and analysis

SAS Procedures: Print, Means, Univariate, Freq, Sort, Summary, Format, Transpose, Compare, SQL, Tabulate, Import, Export,

Operating systems: Windows: NT, XP, 2000, and UNIX

Office tools: MS Word, PowerPoint, EXCEL

PROFESSIONAL EXPERIENCE

Tata Consultancy Services (Feb2016 – Jun2016)

Teamware Solutions (Apr2015 – Jan2016)

SAS Programmer

Responsibilities:

Using Base SAS and Macros to map and analyze Client's Data (CDASH, SacQ) into Client's format.

Mapping data from different standards to client specific data standards using client’s internal tools based on SAS.

Coding and generating reports in SAS to analyze and verify the mapped data.

Convert data from different Pharma standards to Client Specific Data Standards using SAS on Unix environment

Perform data extraction, coding, validation, per specification.

Max Neeman International Pvt Ltd, New Delhi (Oct 2013-Apr2015)

SAS Programmer

Responsibilities:

•Performed validation of SAS-generated outputs (table, listings) via independent programming

•Created efficacy/safety Lab outputs as per SAP along with Stats team.

•Responsible for the proper coding, documentation and validation of SAS programs/macros/procedures to produce the standardized data display

•Established and maintained libraries of fully documented and validated SAS programs/ macros / procedures which are used and recycled

•Ensured proper and consistent implementation and maintenance of guidelines and standards within the department

•Data migration/upload to SAS environment from Excel, CSV, Tab, DLM and flat files.

•Prepared documentation of the process for maintenance purpose.

Max Neeman International Pvt Ltd, New Delhi

Clinical Trial Assistant

Jul 2011-Oct 2013

Responsibilities:

•Maintain all Project related files, ensure timely completion, accuracy & distribution.

•Reviewing the ICFs and other patient facing documents.

•Coordinate with the vendors/ translation agencies for translation of study documents

•Preparation of SIV binders EC Dossiers and dispatch to sites

•In conjunction with the pharmacist & monitor, ensure optimal CTM supplies at the site

•Assist monitor in ensuring collection of all data and used/ unused study supplies, as applicable, for return to the Sponsor/CRO

•Assisting in collection and compilation of Weekly Reports from the sites and non-study related documents.

•Day to day coordination with the operations team.

•Assist study team in ensuring the timely accurate and complete collection of study data.

•Assist the Project Manager for all audits and inspection.

•Monitor and track patient enrollment and study progress.

•Feasibility coordinator in Feasibility process.

EDUCATION

•P.G Diploma in Clinical Research in 2011. (Sharda University, India)

•B.Sc in Life Sciences in 2010. (Jammu University, India)

•Certification-SAS Certified Base Programmer for SAS9, SAS Institute, USA

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