Aditi Agarwal
SDTM Programmer
Noida, India
Summary
Summary
- Certified Base SAS programmer with almost 13 years of experience in analysis of large sized data.
- Experienced in creating and validating SDTM data using SAS and various standards, including CDISC standards/Pinnacle.
- Experienced in running P21 Enterprise and interpreting the issues along with resolving the errors/Warnings across different Pinnacle Engines.
- Experienced in creating submission packages and Regulatory inspections(offline and remote both) for different Regulatory Authorities like FDA, PMDA EMA,NMPA etc.
- Hands on experience on Life Science Analytics Framework(LSAF), a product of SAS which helps in creating and managing repository of clinical trials conducted for a sponsor.
- Experienced in generating the SAS listings to monitor the data during conduct phase using Qliksense.
- Worked as Lead Clinical Data Manager for different trials conducted across geographies in different phases of clinical trials.
- Experienced in end to end activities from study start-up to study closure including Database Lock activities and data standardization (SDTM) using various EDC systems and SAS programming.
- Building/Reviewing of Annotation,Metadata(raw and SDTM),Define.xml and mapping raw data to generate CDISC-SDTM datasets as per client specification.
- Expertise in creation of Data Validation Plan and User Acceptance Testing of Electronic Data Capture(EDC) including ePRO data.
- Experienced in Data Extraction, Listings and Reports preparation and Analysis.
- Expertise in managing clinical data, retail FMCG data and handling various databases using Base SAS, SAS/MACRO, SAS/SQL.
- Expertise in writing New Macros/Updating existing Macros and modifying the existing SAS programs to save time and resources.
- Experience in creating and maintaining documentation in eTMF using Trial master index.
- Is an effective problem solver who can work independently or as an integral part of the team with good communication skills.
- Worked as a Technical Team Lead to manage the team of 11 people.
Overview
14
14
years of professional experience
1
1
Certification
Work History
SAS SDTM Programmer and Clinical Data Manager
Tata Consultancy Services
06.2014 - Current
- Review study protocol, co-coordinating with the clinical team, Statistician, Programming and Medical teams to collect the study specific information
- Performing SDTM compliant metadata set up and creating annotated CRFs, define file, study flowchart and blank SAS data shells for the vendor to get the study set up done in EDC system using SAS
- Defining all study specific/standard validation/edit checks and reports to get set up in the EDC system
- User Acceptance Testing of EDC and sample datasets
- Monitoring subject enrollment & potential issues during study conduct & suggesting solution for the same using SAS
- Have been involved in ensuring all the points required to get closed before declaring a study as cleaned file and to have the final data lock
- Creation and Validation of SDTM datasets using the specifications using SAS and running P21E to resolve the errors and making SDTM and Define.xml CDISC compliant.
- Tracking all the study deliverables during all the phases (start up, conduct and closure) and take mitigation actions for the identified gaps
- Dealing with client's vendors for EDC setup, validation, external data integration, database structure etc and ensuring trial is set-up and designed as required
- Imparting trainings to the new joiners and team subordinates in CDM/SDTM process, systems, tools, requirements and deliverables
- Review the study deliverables, CRFs (Case Report form) and SDTM datasets generated by team members
- SAS Report creation by using Statistical SAS procedure using SAS analysis datasets for different phases of Clinical Trials in Life Science Analytics Framework.
Business Analyst
Tata Consultancy Services
08.2011 - 06.2014
- Developed SAS programs to generate analysis outputs as specified in the statistical analysis plan
- Insights to client on Retail FMCG data & also calculating sample size using Excel for geographies all over the world
- Prepare questionnaire design, sample design, Universe estimation, Universe monitor and Universe Update
- Statistical Modeling using Regression on raw data to produce output
- Doing stratification at both Primary Sampling Unit and Secondary Sampling unit
- Coordinating meetings/calls with onshore counterpart/clients to discuss issues and outcome of analysis
- Acted as Team Lead to manage team of 6 people.
Analytics Consultant/Digital Marketing-In charge
Redwood Associates
08.2010 - 08.2011
- Developed SAS programs to generate analysis outputs as specified in the statistical analysis plan.
- Worked for a renowned Real Estate Company to provide SAS based analysis reports on their potential buyers and projections.
- Provided SAS and Excel training in corporate like Cognizant through STC, Clinotek, Citibank, Genpact, BSBS Management College and for all the retail batches held in the training institute
- As Digital Marketing In-charge: Prepared the road map and strategy for Reducate (internal product). Designed the questionnaires for the experts and interviewed them to take share their knowledge through Reducate platform
- Designed the online/offline marketing strategy for many new courses launched in the institute and did sales also for the same.
Education
Bachelors in Technology - Information Technology
SRMSCET
Bareilly2010
Skills
SAS Base and SQL
Certification
Base SAS certification
Timeline
Base SAS certification
05-2016
SAS SDTM Programmer and Clinical Data Manager
Tata Consultancy Services
06.2014 - Current
Business Analyst
Tata Consultancy Services
08.2011 - 06.2014
Analytics Consultant/Digital Marketing-In charge
Redwood Associates
08.2010 - 08.2011
Bachelors in Technology - Information Technology
SRMSCET
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