S*************e

Featured
Trainee Clinical Trial Data Analyst
October 18, 2000

About Candidate

I am Shraddha Ahire and a post graduate in Biotechnology with sheer professional experience in Clinical Trial Data Analysis through certain skills that I have worked with including Generating, Manipulating, Validating datasets using base SAS, Advance SAS, SQL, Macros, Power BI, SDTM and ADaM standards.

Having spent the past few months as a trainee Clinical Trial Data Analyst at Kite-AI, I have not only developed robust problem-solving and teamwork skills, bust also acquired best knowledge in Clinical SAS programming and Industry standards.

As of today, I have worked on below mentioned Projects:

Technical Project Experience

CRF Annotations:
• Role: Developer
• Duration: 13 hours
• Description: Annotated Blank CRF into aCRF using SDTMIG v3.4

Development of SDTM Domain Dataset:
• Role: Developer
• Duration: 18 hours
• Description: Creating Demography dataset by writing independent code in SAS code

Development of Analysis Dataset:
• Role: Developer
• Duration: 140 hours
• Description: Generating Laboratory Analysis dataset by using raw laboratory data

Analysis Dataset Validation:
• Role: Developer
• Duration: 128 hours
• Description: Validating information with analysis datasets by writing independent SAS code

Integrating Data for PK Analysis:
• Role: Developer
• Duration: 130 hours
• Description: Writing independent SAS code for the technical integration of PK concentration & corresponding PK data in clinical database.

Generating Reports:
• Role: Developer
• Duration: 200 hours
• Description: Generating Demography and adverse event report by MedDRA system organ class with SAS code using analysis datasets.

Validating Reports:
• Role: Developer
• Duration: 120 hours
• Description: Validated RTF Report writing independent SAS code.

Education

P
Post Graduate in Biotechnology 2023
Savitribai Phule University

Pursued Post-graduation in Biotechnology, gained vast knowledge in the fields of Bioinformatics, Pharmaceuticals and drug design, Molecular Biology, Genetics and Advanced Biochemistry.

Work & Experience

T
Trainee Clinical Trial Data Analyst June 26, 2023
Kite-AI Technologies Pvt. Ltd.

As a Trainee Clinical Trial Data Analyst, supports the Statistical Programming team in the Day-to-Day operations as per the tasks allocated from time to time and ensuring the best Turnaround time.

Skills

SAS (Base + Advanced)
92%
Clinical Research Domain
90%
CDISC
85%
SDTM
85%
ADaM
85%
Power BI
90%