Senior Clinical Data Scientist

Jobtailor; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Jobtailor in Bengaluru is seeking a Clinical Data Programmer to work on SDTM/ADaM deliverables and eCRFs, ensuring regulatory compliance. You will collaborate with CROs and cross-functional teams to finalize datasets and create TFLs, while supporting CSR and DSUR documentation.

You should have 2-3 years of programming experience, proficiency in SAS or R, and a good understanding of clinical data models. Excellent English communication and independent work style are essential.

Qualifications

• Bachelor's or Master's degree in life sciences, natural sciences, engineering, or equivalent qualifications
• 2-3 years of programming experience, preferably working with biological data or equivalent knowledge through relevant practical experience
• Proficiency in programming languages such as SAS or R
• Experience with clinical database technologies, data models, and advanced programming techniques
• Demonstrated ability to collaborate effectively across professional and regional borders in a multinational environment
• Strong analytical skills combined with independence, self-drive, and accountability in managing variable workloads
• Excellent communication skills with fluency in written and spoken English, and the ability to explain technical issues to both peers and stakeholders
• Basic understanding of the pharmaceutical industry and key elements of the clinical development value chain

Responsibilities

• Managing assigned tasks within clinical trials, including finalizing SDTM and ADaM deliverables, preparing and reviewing annotated CRFs (aCRFs), generating SDTM datasets, programming ADaM, and creating TFLs in compliance with regulatory standards
• Contributing to trial setup activities such as developing eCRFs, Data Flow Plans, metadata specifications, mock TFLs, SDRG, ADRG, and Define.xml
• Supporting Clinical Study Reports (CSRs), Risk Management Plans (RMP), Investigator Brochures (IB), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and public disclosure deliverables
• Collaborating with internal and external stakeholders including CROs, regulatory authorities, and scientific communities to ensure seamless trial execution
• Sharing best practices, contributing to process optimization, and supporting change management initiatives that advance our data standards and programming practices
• Providing training and support for colleagues on statistical computing environments, system usage, and SOP understanding
• Ensuring all documentation and programming practices meet Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) standards

Skills

SAS

R

Clinical data

Data standards

Team collaboration

Education

Bachelor's or Master's in life sciences

Tools

Define.xml

Job description

Responsibilities

• Managing assigned tasks within clinical trials, including finalizing SDTM and ADaM deliverables, preparing and reviewing annotated CRFs (aCRFs), generating SDTM datasets, programming ADaM, and creating TFLs in compliance with regulatory standards
• Contributing to trial setup activities such as developing eCRFs, Data Flow Plans, metadata specifications, mock TFLs, SDRG, ADRG, and Define.xml
• Supporting Clinical Study Reports (CSRs), Risk Management Plans (RMP), Investigator Brochures (IB), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and public disclosure deliverables
• Collaborating with internal and external stakeholders including CROs, regulatory authorities, and scientific communities to ensure seamless trial execution
• Sharing best practices, contributing to process optimization, and supporting change management initiatives that advance our data standards and programming practices
• Providing training and support for colleagues on statistical computing environments, system usage, and SOP understanding
• Ensuring all documentation and programming practices meet Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) standards

Requirements

• Bachelor's or Master's degree in life sciences, natural sciences, engineering, or equivalent qualifications
• 2-3 years of programming experience, preferably working with biological data or equivalent knowledge through relevant practical experience
• Proficiency in programming languages such as SAS or R
• Experience with clinical database technologies, data models, and advanced programming techniques
• Demonstrated ability to collaborate effectively across professional and regional borders in a multinational environment
• Strong analytical skills combined with independence, self-drive, and accountability in managing variable workloads
• Excellent communication skills with fluency in written and spoken English, and the ability to explain technical issues to both peers and stakeholders
• Basic understanding of the pharmaceutical industry and key elements of the clinical development value chain