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FeaturedAbout Candidate
[10:57]Kumbhare Bhavana Intern
I am Kumbhare Bhavana , I have completed my masters in Statistics from Shivaji university Kolhapur , currently looking job , I have Knowledge about below tools
1. Biostatistcs : Biostatistics knowledge: Sample size calculation Various parametric and non-parametric biostatistical test Basic understanding in SAP (Statistical Analysis Plan)
2. Clincal Research Domain
3. SAS Programming (Base & advanced )
I have gaining the professional internship experience through KITE-Ai Technologies in Clinical Data Analytics using SAS Programming .
As of todays, I have completed below mentioned project .
1. Development of Analysis Dataset : Duration: 29-Mar-2022 to 15-Apr-2022 Description: Generate Laboratory Analysis Dataset (ADLB) by using raw data (LB). Developed Analysis dataset (ADLB), to visualize the change of lab test results based on overall lab test Distribution for the study. Majority of Lab information are directly extracted from SDTM.LB. Derived the Baseline, Change, Percent Change and visit information.
2. Validation of ANALYSIS DATASET : Duration: 1/May/2022 – 15May 2022:Description: Generate avsn by using raw data (vsn) I have derive Visit number, Baseline flag value, Post-baseline value , Vital sign , parameter code, VSN value,Baseline VSN value, Change from baseline VSN value, Vital sign duration in study .
3. CRF Annotation :
4. Report generation: Duration: 29-Aug-2022 to 9-Aug-2022 Description: Generate 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. 5. Report generation: Duration: 1-Oct-2022 to 12-Oct-2022 Description:Validate RTF reports by writing independent SAS code.
6. Report Generation: Duration: 1-Oct-2022 to 12-Oct-2022 Description:
Generate the ‘Summary of Physical examination (Safety Analysis Set)’
report by writing independent code in SAS.
7. SDTM Dataset Development Duration: 13-Oct-2022 to 21-Oct-2022 Description: Create SDTM Demography domain dataset by writing independent code in SAS as per specification
Technical Project Experience
1. Development of Analysis Dataset :
Duration: 29-Mar-2022 to 15-Apr-2022
Description: Generate Laboratory Analysis Dataset (ADLB) by using raw data (LB). Developed Analysis dataset (ADLB), to visualize the change of lab test results based on overall lab test Distribution for the study. Majority of Lab information are directly extracted from SDTM.LB. Derived the Baseline, Change, Percent Change and visit information.
2. Validation of ANALYSIS DATASET :
Duration: 1/May/2022 - 15May 2022:
Description: Generate avsn by using raw data (vsn) I have derive Visit number, Baseline flag value, Post-baseline value , Vital sign , parameter code, VSN value,Baseline VSN value, Change from baseline VSN value, Vital sign duration in study .
3. CRF Annotation :
4. Report generation:
Duration: 29-Aug-2022 to 9-Aug-2022
Description: Generate 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.
5. Report generation:
Duration: 1-Oct-2022 to 12-Oct-2022
Description: Validate RTF reports by writing independent SAS code.
6. Report Generation:
Duration: 1-Oct-2022 to 12-Oct-2022
Description:
Generate the ‘Summary of Physical examination (Safety Analysis Set)’
report by writing independent code in SAS.
7. SDTM Dataset Development
Duration: 13-Oct-2022 to 21-Oct-2022
Description: Create SDTM Demography domain dataset by writing independent code in SAS as per specification