Job Role : Statistical Programmer

Greetings From You & I Consulting!

You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India.

*Hurry Do Not Miss This Prospect To Work For Global Giant MNC.

We are hiring for the below locations under Statistical Programmer role!!

*Open Locations :-

Ahmedabad /Mumbai/ Pune/ Bangalore

*Mode Of Interview - Virtual

*Mode Of Work :- Work From Office

- CTC Upto - 7.5 Lpa To 20 Lpa

*Call Now our HR Specialist:-@Saloni - 70471 60133 & @Arunima-(phone hidden) (call or whts app)*or email your CV to [email protected] & [email protected]

Education

Btech / Any life Science Graduate

Job Descriptions

SDTM standards for Phase I-III clinical trials.

- Validated SDTM and ADaM datasets to ensure compliance with CDISC standards and regulatory requirements.
- Created Define.xml files to accompany submission-ready datasets.
- Collaborated with statisticians, data managers, and clinical teams to ensure accurate and timely delivery of datasets.
- Used Pinnacle 21 to validate datasets and resolve compliance issues.
- Data sub setting and summarizing as per the report.
- Testing those reports to check whether they are meeting the client expectations or not
- Annotating CRF based on SDTM mapping as a part of SDTM Submission.




- Preparing SDTM mapping specifications and programming for generating CDISC SDTM compliant datasets and transport files from raw data in database (CRF), based on study documents such as

CRF.

Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature.

- Assess the medical relevance and causality of adverse events reported in ICSRs.
- Identify and evaluate potential safety signals and perform appropriate follow-up actions as necessary.
- Ensure accurate and timely reporting of serious and non-serious adverse events to regulatory authorities.

****Call Now our HR Specialist:- @Saloni - (phone hidden) &@ Arunima- (phone hidden) (call or whts app)or email your CV to [email protected] & [email protected]

****

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📌 Statistical Programmer Hiring For - Global MNC- CTC 20 LPA !! (Ahmedabad)
🏢 YOU u0026 I Consulting
📍 Ahmedabad