Y. Naga Rama Ramesh

Mobile:+91-958*******

Email:adnx3m@r.postjobfree.com

CAREER OBJECTIVE:

To work for a progressive organization in a highly motivating and challenging environment that provides the best opportunities to grow and utilize my potential to the fullest to achieve the organization’s goal while achieving my personal goals.

SUMMARY:

Total around 2.2 years of Professional Experience.

Experience in Analysis, Design of applications.

Expertise in analyzing and coordinating clinical trial data, build the SDTM datasets, using SAS in accordance with the Statistical Analysis Plan (SAP),Standard Operating Procedures(SOPs) and departmental guidelines.

Good experience on creation SDTM datasets.

Strong knowledge involving all phases (I-IV) of clinical trials.

Proficient in understanding different clinical trials data like Demographic, Adverse Events (AE), Findings etc.

Proficiency in understanding of Study Protocols, SAP and A-CRF.

Hands on experience creating and debugging of SAS Macros.

Knowledge of using PROC SORT, PROC REPORT, PROC MEANS, PROC FORMAT, PROC FREQ and PROC TRANSPOSE.

Knowledge on the concepts of SAS.

PROFESSIONAL EXPERIENCE:

A&A Innovative Solutions Statistical Programmer

May 2019 to – Till now

Sdtm programmer

Phase-I & II Clinical Trial study

Therapeutic area : Asthma.

Title1. : phase I & II Multicenter, double blinded, randomized, placebo-controlled

clinical trial to

evaluate safety & efficacy of *** (a fixed dose combination tablet of *** ) in Asthma

patients.

Role and Responsibilities:

To review the protocol, statistical analysis plan (SAP), TFL shells, Dataset specifications, A&R grid.

Created datasets in SDTM (3.2) standards from raw datasets

Modified existing datasets using Set, Merge, and Sort, update, Formats, Functions, Conditional statements and procedures.

Experience in data mapping from non-CDISC SDTM to SDTM and From SDTM to ADAM Standards.

Involved in the development of datasets – Demographic data tables, Subject Disposition, Adverse Events tables, Medical history,Lab, Subjects visits etc.

Involved in multiple projects and interacted with other Programmers, statisticians and data managers to analyze data.

Creating macros to optimize code

Mapping multiple datasets to create standard dataset as per SDTMIG.

Understanding of Protocol and CRF data mapping.

Vendor data mapping.

Performing cross validating SDTM datasets for better quality.

Supporting ADHOC requests

QUALIFICATIONS:

University : Green Royal Academy of Pharmacy (jntuk).

Degree : Masters of Pharmacy.

Aggregate : 90%.

DECLARATION:

I hereby declare that the above information given is true to the best of my knowledge and belief.

Place : Hyderabad Y. Ramesh

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