Sahithi Jayanthi

Project 1:

Project Details : Treatment Patters and Outcome across the disease Continuum in patients with CAD and/or PAD

Client details: A Leading pharmaceutical and biotechnology company in Germany

Role: Lead Biostatistician/ Senior Statistical Programmer

Duration: March 2023 - Current

Key Responsibilities:

• Leading end to end delivery of whole project from specification creation, SAP review and update , generating ADaM and TLF's , final analysis of dry-run tables and submission , creating and presenting Validity data review(VDR) report to client
• Project has currently gone through 2 dry run cycles and final draft tables submission is due in October 2023
• Creation of two specifications , one for ADaM's and another one for ad-hoc request for censored data.
• Reviewed SAP document from client .
• Created and reviewed ADaM datasets (Total 17 in project)
• TLF creation and review(Tables 18 , 5 listings delivered and 60 in Progress)
• Created Validation Data Review(VDR) report and presented to client and received excellent feedback.
• Creation of trend reports quarterly to check patterns in data.
• Worked on Censoring data for specific population from dataset after specific period in study.

Project 2:

Project Details : Treatment of High and Very high risk dyslipidemic patients for the prevention of cardiovascular events in Europe- A multinational Observational Study

Client details: A Leading pharmaceutical and biotechnology company of Japan , based in Germany

Role: Senior Biostatistician/ Senior Statistical Programmer

Duration: September 2022 - February 2023

Key Responsibilities:

• Responsible for doing final review / QC of all TLF's output review before submission to client .
• Dealing with Adhoc requests in project.

Project 3:

Project Details : Observational Study Evaluating Effectiveness and Safety of Real World Treatment with JIVI in Previously treated patients with Hemophilia A

Client details: A Leading pharmaceutical and biotechnology company in Germany

Role: Senior Biostatistician/ Senior Statistical Programmer

Duration: September 2022 - February 2023

Key Responsibilities:

• Responsible for creation of patient related outcome(PRO) dataset
• Responsible for creation of four TLF's
• Responsible for output review of TLF's for other team members.
• Responsible for creation of macro which gives differences in specification and ADaM datasets

Project 4:

Project Details : Randomization/Random Patient Selection Procedure

Client details: A Leading pharmaceutical and biotechnology company in United Kingdom

Role: Lead Biostatistician

Duration: October 2022 - Current

Key Responsibilities:

• Creation of macro to generate randomization list for duration of study
• Generating randomization list upon each request according to site,country and caseload

• Worked for client Roche AG, which is Swiss multinational healthcare company based out of Switzerland.
• Part of multiple teams like DSS(Data Sharing Specialist) , SPA(Statistical Programming and Analysis) and Statistical Monitoring.
• Performed execution of programs for Data Anonymization process .
• Validated anonymized datasets as per normal QC process.
• Created Macros to support new scope of work.
• Developing SDTM datasets from raw datasets.
• Developed SAS programs for ADAM datasets as per specifications.
• Generating tables,listings and figures in SAS.
• Analyzing data using PROC GLM, PROC MEANS, PROC FREQ etc.
• Worked on anonymization requests using R language as proof of concept and trained whole team in R Language. This POC was done to see if we could start using R for some of anonymization requests instead of using SAS.
• Worked on Pinnacle21 validation tool for validating datasets and creation of define xml file for FDA submissions.
• Hosted team meetings with client to update status of deliverables.
• Provided multiple trainings related to SAS and anonymization of various requests to new members joining the team.

• Worked as Online Subject Matter expert for Statistics.
• Resolve complex Statistical queries posted on Chegg website and come up with best solution as soon as possible.
• Take online doubt clearing sessions with students on key statistical concepts .

• Learned Base and Advanced SAS along with basics of Clinical research
• Theoretical knowledge of phases (I-IV) of clinical trails.
• Experience in producing HTML ,RTF ,PDF formatted reports using SAS/ODS.
• Experience of using SAS Functions
• Experience of using KEEP, DROP options in Data Step
• Experience of generating report using SAS procedures PROC REPORT
• Creating Tables,Figures and Data listings(TLF)
• Worked on some real life assignments. Few assignments given were: CRF annotation , ADVS creation, QC of SDTM datasets and Graph generation.