swetha resume

1. RESUME
TADIGOTLA SWETHA
Email ID: [email protected]
Mobile : 91+8884666345
Summary:
Working as Clinical trials programmer with around 2.2 years of experience especially in Clinical domain
with proficient knowledge in TFL’s, SDTM, ADaM and DEFINE.XML models.
Certified Base SAS Programmer for SAS 9.
Able to handle project deliverables independently and deliver quality outputs under stringent timelines.
Maintain good interaction with study statistician and team members to get work done under timelines.
Experience in Phase I, II and III of Clinical Trials and involved in SAS programming for
creating SAS datasets, analyzing the data, generated tables, listings and figures (graphs) (TLFs).
Experience in both Safety and efficacy analysis outputs.
Have good Knowledge in project related documents like : CRF, aCRF, SAP, CSR, Protocol,
SOP’s ,CDISC SDTM ,ADaM & DEFINE.XML Models, WHO drug dictionary, MedDRA.
Have worked on Transport file creation (XPT).
Extensive experience in DATA step programming, various base SAS procedures and statistical
procedures including thorough knowledge of SAS Macro Language.
Working experience in CDISC models SDTM & ADaM datasets creation and validation of produced
datasets and DEFINE.XML using standard guidelines.
Professional Experience
Working as Associate Stat Programmer in Quintiles technologies Pvt ltd, Bangalore from March 2014 to
till date.
Responsibilities:
SDTM:
·Checking the data issues thoroughly between the data transfers received from CDM team. Also the
subsequent transfers were compared with the earlier ones to check the data consistency and the variable
attributes and also to point out the resolution of already identified issues with earlier transfers.
·Have good knowledge on SDTM domains like ‘Interventional’, ‘Events’,‘Findings’ & ‘Special purpose’.
·Production and Validated of SDTM datasets using mapping specification.
·Experienced in validation of SDTM datasets with open CDISC validation tool or using inbuilt macros.
·Reconciliation of external data with CRF data and reporting the issues that were not reconciled either in
CRF data or external file to DM and getting the issues resolved.
·Created SAS datasets (.xpt files) for electronic submission as per client requirement.
·Generated the define.xml and data Reviewer’s guide (Metadata for submissions).
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2. ADaM:
·Experienced in writing CDSIC standard dataset specifications and reviewed using ADaM Implementation
guide or sponsor specified requirements as well as based on Shells, and SAP and analysis performed.
·Checking the data issues thoroughly between the data transfers received from SDTM team. Also the
subsequent transfers were compared with the earlier ones to check the data consistency and the variable
attributes and also to point out the resolution of already identified issues with earlier transfers.
·Follow specifications to create and validate ADaM datasets from RAW datasets or SDTM datasets.
·Validation of datasets using double programming and cross checking of metadata against standards
(ADaM IG).
·Creating and validated ADaM datasets based on sponsor requirement, as well as based on Shells, and SAP
and analysis performed.
·Creating population indicator flags based on SAP.
·Interacting with lead and statistician on the additional derivations if required in the study.
·Creating new observations (Derived records) if required for analysis.
·Experienced in validation of ADaM datasets with open CDISC validation tool or using inbuilt macros.
·Created SAS datasets (.xpt files) for electronic submission as per client requirement.
·Generated the define.xml and data Reviewer’s guide (Metadata for submissions).
TLF:
·Generating Tables, Listings and Graphs based on SAP and shells.
·Generated Safety and PK/PD TLF’s.
·Performed QC/Validation activities on the production TLF’s.
OTHER:
·Setup of programming environment for the study and share study information across team by arranging
study related meetings.
·Participate in Kick Off meeting, read and understand thoroughly about study documents like SAP,
Protocol and Mock shells.
·Work assignment among the team and coordinate with study statistician and team to get work done with in
timelines with quality deliverables.
·Update study assignment trackers on day to day basis and assist fellow programmers for programming
issues.
Professional Achievement:
·Got several awards for best performance in clinical programming, Team work and given trainings to
within team as well as to the new joiners.
·Appreciated for submission of Quality deliverables under stringent timelines.
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3. ·Creation of define.xml by using Open CDISC Validator 2.0.1 and given training across global team.
Educational Qualifications:
·MASTERS IN PHARMACY from JNTU (20010-2012), Hyderabad.
·BACHELOUR IN PHARMACY from Dr. MGR Medical University (2006-2010).
Declaration:
I hereby declare that all the information mentioned above is true to the best of my knowledge.
Place: Bangalore. (Tadigotla Swetha)
Date:
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