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Trainee Data Analyst (Clinical SAS)
January 14, 1997

About 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

B
Bachelor of Pharmacy 2020
Poona College of Pharmacy

Work & Experience

P
Project Trainee June 20, 2022
KITE-AI Technologies Pvt. Ltd.
C
Clinical Research Coordinator June 24, 2024 - June 24, 2024
Symbiosis Universiy Hospital & Research Center

• 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

I
Intern CRC June 24, 2024 - June 24, 2024
Xylem Research LLP

• 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.

Skills

Base SAS
90%
Advance SAS
85%
Clinical Research
100%
CDISC- SDTM & ADAM
90%

Awards

G
GPAT Qualified 2020
I
ISTE Student Chapter Scientific Model 2019
Bronze

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