Novotech Hiring Clinical Data Programmer I (SDTM)
Are you seeking Novotech Careers India or a Clinical Data Programmer Job in Bangalore? Leading global biotech-focused clinical contract research organization (CRO) Novotech has opened applications for Clinical Data Programmer I (SDTM) (Job ID: 4181) at its Bangalore office.
This SDTM datasets creation vacancy is ideal for science, statistics, or computing graduates with at least 1 year of experience in SAS programming, clinical database design, annotated CRFs, and statistical analysis plans (SAP). Candidates will coordinate directly with global clinical trials teams. To draft a resume detailing your SDTM mapping or clinical validation milestones, read our guidelines on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Particular | Details |
|---|---|
| Company | Novotech (Novotech India Private Limited) |
| Position | Clinical Data Programmer I (SDTM) |
| Job ID | 4181 |
| Job Location | Bangalore, Karnataka, India |
| Employment Type | Full-Time |
| Department | Clinical Data Programming / Biostatistics |
| Experience Required | 1 Year+ (SAS/SDTM programming experience preferred) |
| Qualifications | Bachelor's Degree in Life Sciences, CS, Statistics, Mathematics, or Analytical disciplines |
| Expected Salary | ₹6,00,000 – ₹10,00,000 per annum (Estimated) |
💼 Key Responsibilities
- SDTM Programming: Perform SDTM mapping and dataset generation based on clinical trial protocols, annotated CRFs, and statistical analysis plans.
- CDISC Standards: Create and maintain compliant SDTM datasets following CDISC implementation guidelines.
- Quality Control: Conduct quality reviews, peer reviews, validation, and double programming of clinical datasets.
- Submission Packages: Develop submission documentation including Define.xml, Reviewer’s Guides, and FDA data transfer files.
- SAS Development: Write, debug, and maintain SAS programs with complete code comments and traceability.
- Team Collaboration: Partner with biostatisticians, statistical programmers, and database coordinators.
To learn how clinical programmer salaries compare to conventional pharmacovigilance drug safety associate and clinical study coordinator structures, read our report on Pharmacovigilance Salary: India vs USA.
🎓 Required Qualifications & Skills
- Education: Bachelor's or Master’s degree in Life Sciences, Computer Science, Statistics, Mathematics, or related quantitative fields.
- Programming: Prior project or work experience in SAS programming (Base/Macro) for data manipulation.
- Standards Knowledge: Good understanding of CDISC SDTM guidelines, SDTM IG, and dataset validation tools (like Pinnacle 21).
- Data Manipulation: Ability to read clinical databases, translate raw datasets, and build regulatory schemas.
- Communication: Good written and verbal English communication for cross-functional study team calls.
For science graduates evaluating clinical programming tracks compared to conventional laboratory quality control or sales careers, read our analysis on B.Pharm Careers after Graduation: India vs USA.
🎁 Why Join Novotech?
- Work with a top-tier global CRO operating across 30+ international office locations.
- Diverse exposure compiling regulatory data submission packages for international agencies.
- Competitive base pay, paid parental leave, and flexible working arrangements.
- Comprehensive professional development and biostatistics mentorship programs.
To review your basic knowledge of clinical databases, safety protocols, and GCP guidelines before your interviews, try our interactive Clinical Trial Assistant (CTA) Quiz.
💡 Clinical Programmer vs Healthcare IT
Clinical Data Programmers map CDISC SDTM datasets, compile Define.xml packages, and debug SAS programs for trials, whereas Healthcare IT professionals support software deployments. To explore these differences, read our comparison on Healthcare IT vs Clinical Healthcare.
📝 Resume Tips for Novotech Candidates
- Detail SDTM Domains: List specific SDTM domains (like DM, AE, VS, LB) that you have mapped or verified during past projects.
- List SAS Techniques: Mention base SAS skills, merge statements, macro definitions, and data steps you regularly program with.
- Highlight QC Experience: Explicitly mention if you have run validation tools like Pinnacle 21 or performed double-programming checks.
💬 Novotech Clinical Programmer Interview Questions
- Q1. What is the difference between SDTM and ADaM datasets?
Answer Guidance: SDTM (Study Data Tabulation Model) is the standard format for presenting raw clinical trial data to regulatory authorities. ADaM (Analysis Data Model) is built using SDTM datasets and is structured specifically to perform statistical analysis and generate tables, listings, and figures. - Q2. What is the purpose of the Define.xml file in a CDISC submission?
Answer Guidance: Define.xml is a metadata documentation file required for regulatory submissions. It describes the structure, domains, variables, code lists, and origin of all datasets in the SDTM package, helping reviewers navigate the submitted data. - Q3. Explain how you would check for data compliance in an SDTM dataset.
Answer Guidance: I use standard validation rules using software like Pinnacle 21. It checks for variable length errors, missing required values, code list discrepancies, and alignment with the SDTM Implementation Guide (IG). I also perform manual program logs audits.
🚀 How to Apply?
Interested and eligible candidates can submit their applications directly via Novotech's Oracle Cloud recruitment board. Click the button below to apply:
Apply Online – Novotech Oracle Career Board❓ Frequently Asked Questions
Q. Do I need experience with SAS base coding to apply for this Clinical Data Programmer I role?
Yes, prior experience or training in SAS programming is preferred to manage clinical datasets.
Q. Which degrees are accepted for this Novotech vacancy?
Novotech accepts degrees in Life Sciences, Computer Science, Statistics, Mathematics, or related quantitative disciplines.
Q. What is the location of the position?
This is a full-time position based onsite or hybrid out of Novotech's office in Bangalore, Karnataka, India.
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