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FeaturedAbout Candidate
I am a B.Pharm graduate .Currently undergoing an apprenticeship with Kite AI Technology in Clinical Data Analytics using SAS and related tools.With previous experience in Clinical research, I am honing my skills further to be ready for the right opportunity.So far, I have upgraded myself with the following skills-
1. Base SAS
2. Advance SAS
3. CDISC- SDTM and ADAM
4. Clinical Research Operations (Clinical Trials phase I -IV)
I am always in the learning and exploratory phase and looking forward for the right opportunity.
GPAT Qualified 2020
Technical Project Experience
CRF Annotations
- Tool: SDTM-IG v3.4
- Role: Developer
- Duration: 60 hrs
- Description:
- Annotations done according to data submitted within SDTM (CDISC)
- Each unique occurrence of submitted data annotated on the CRF
- Following CDISC controlled terminologies, code list and formats referring to SDTMIG
- Text-based and searchable Annotations
Development of SDTM Domain Dataset
- Tool: SAS v9.4 and SDTM-IG v3.4
- Role: Developer
- Duration: 72 hrs
- Description:
- Creating SDTM Demography domain dataset by writing independent code in SAS
- Using raw data and SDTM-IG for variable type.
Development of Analysis Dataset
- Tool: SAS v9.4 and ADaMIG_v1.3
- Role: Developer
- Duration: 72 hrs
- Description:
- Generating Laboratory analysis dataset (ADLB) by using raw lab data (LB)
- Structure – One record per subject per lab test per timepoint (lbdy/lbdtc).
Analysis Dataset Validation
- Tool: SAS v9.4
- Role: Developer
- Duration: 72 hrs
- Description:
- Validating analysis datasets by writing independent SAS code.
- Comparing the resulting dataset with dataset which is already generated and providing compare output in the form of .lst file as well as create a validation findings document using the template provided in case we find discrepancies
Data Integration for Pharmacokinetic Analysis
- Tool: SAS v9.4
- Role: Developer
- Duration: 72 hrs
- Description:
- Write an independent SAS code for PK data integration. The PK data integration defines the technical integration of PK concentration data and corresponding Pharmacokinetic (PK) data in the clinical database.
- Creation of derived variables
- Once the final merge is done then Converting the SAS dataset into a SAS transport data.
Report generation
- Tool: SAS v9.4
- Role: Developer
- Duration: 72 hrs
- Description:
- Generating the demography report by writing independent code in SAS using analysis dataset for demography.
- Generating the adverse event summary report classified by MedDRA system organ class by writing independent code in SAS using analysis datasets for demography and adverse event.
Report Validation
- Tool: SAS v9.4
- Role: Developer
- Duration: 72 hrs
- Description:
- Validating RTF reports by writing independent SAS code.
- Generating the listings of compare result and store the output.
R - Project
- Tool: R-Studio
- Role: Developer
- Duration: 72 hrs
- Description: (Analysis and Graph/plot generation)
- Project 1: Covid-vaccine-analysis
- Project 2: Analysis on Diabetes dataset
- Project 3: Analysis on Health care dataset
Education
Work & Experience
• Pune Knowledge Cluster study – Covid Vaccine • IRIS ICU registry study • BIRAC- Site setup and data collection and interpretation • Community outreach programmes • Data handling and analysis, MS Excel
• Managing multiple sites at Sahyadri hosp. Ruby Hall Clinic & Noble Hosp. • Trial related all documentation, maintain ISF, Temp. Log, e-CRF filling. • Patient Counselling for ICF. • Maintaining and managing smooth communication between all parties (sponsor, PI, Patient, vendor etc.) Studies – Ca Breast (TNBC, Premenopausal Adv.) Ca Lung Hepatocellular Carcinoma etc.