As a Clinical Data Programmer I, you will work closely with biostatisticians, statistical programmers, and cross-functional clinical research teams to develop high-quality SDTM datasets, regulatory submission packages, and clinical programming deliverables while ensuring compliance with industry standards.
Job Overview
| Particulars | Details |
|---|---|
| Position | Clinical Data Programmer I (SDTM) |
| Company | Novotech |
| Location | Pune |
| Job Type | Full-Time |
| Experience | Fresher |
| Category / Department | CDM |
| Application Mode | Online |
💡 Editor's Note / Preparation Tip
This role is ideal for professionals with experience in SAS Programming and CDISC SDTM standards who are looking to advance their careers in clinical data programming. Candidates with prior experience in pharmaceutical companies or CROs and a strong understanding of regulatory submission requirements will have an advantage. Before applying, ensure your resume highlights your experience with SAS, SDTM, Define.xml, Clinical Protocols, and Statistical Analysis Plans (SAP).
📝 Job Description
🚀 Clinical Data Programmer I (SDTM) Jobs in India | Novotech
✅ Eligibility Criteria
Applicants should possess:
- Bachelor’s Degree in:
- Life Sciences
- Computer Science
- Mathematics
- Statistics
- Other Quantitative or Analytical disciplines
🌟 Why Join Novotech?
Joining Novotech offers:
- Opportunity to work with a leading global Clinical Research Organization (CRO).
- Exposure to international clinical trials and regulatory submissions.
- Career growth in Clinical Data Programming and Biostatistics.
- Flexible work policies and employee wellness programs.
- Paid parental leave and comprehensive employee benefits.
- Professional development and mentoring opportunities.
- Inclusive, diverse, and collaborative work culture.
- Opportunity to contribute to innovative clinical research that improves patient outcomes worldwide.
🎯 Key Responsibilities
- ✓ Develop SDTM datasets based on clinical protocols, eCRFs, and Statistical Analysis Plans (SAP).
- ✓ Perform SDTM CRF annotation.
- ✓ Conduct SDTM quality control, peer review, and double programming.
- ✓ Develop Define.xml files and reviewer guides for regulatory submissions.
- ✓ Prepare submission-ready datasets and supporting documentation.
- ✓ Follow company programming standards and CDISC guidelines.
- ✓ Maintain well-documented, traceable SAS programs.
- ✓ Manage study documentation, programming files, and project records.
- ✓ Maintain accurate project timesheets.
- ✓ Participate in departmental meetings and cross-functional collaboration.
💡 Required Qualifications & Skills
🚀 Career Guidance & Interview Insights
To help you succeed, we've compiled original preparation guides, resume keywords, and growth analytics for this category of role.
This Clinical Data Programmer I (SDTM) role is a chance to contribute directly to life sciences, patient care, or pharmaceutical advancements. You will work within strict compliance frameworks, ensure rigorous quality standards, and collaborate with technical or medical experts. It is a career path that blends scientific excellence with a deep sense of social purpose.
Healthcare and pharmaceutical professionals grow through specialized scientific experience. Entry-level starts as Lab Technician, Chemist, or Quality Associate, progressing to Senior QA/QC Analyst. Advancement leads to Lab Supervisor, Clinical Project Manager, and senior management roles like Quality Director, VP of Regulatory Affairs, or Chief Scientific Officer.
Expected Technical & Behavioral Questions:
- Q1: How do you ensure compliance with WHO/GMP guidelines during laboratory operations?
Answer Tip: Mention strict adherence to Standard Operating Procedures (SOPs), detailed batch records, regular equipment calibration, and sanitization cycles. - Q2: What steps do you take when a quality deviation is detected in a product batch?
Answer Tip: Outline immediate isolation of the batch, raising a deviation report, root cause analysis (RCA), and initiating CAPA (Corrective and Preventive Action). - Q3: How do you manage safety protocols while handling toxic chemicals?
Answer Tip: Discuss using Material Safety Data Sheets (MSDS), wearing appropriate Personal Protective Equipment (PPE), proper ventilation, and chemical spill kits.
To pass automated ATS (Applicant Tracking System) screening and catch the recruiter's eye, tailor your resume with the following tips:
- Keywords to include: Quality Control (QC), GMP Compliance, FDA Regulations, SOP Documentation, HPLC/GC analysis, Batch Validation, Clinical Trials, Pharmacovigilance.
- Format: List laboratory skills and instruments handled (e.g. HPLC, spectrophotometer) in a dedicated technical matrix.
- Quantify Results: E.g., 'Validated 15 batch formulations under GMP guidelines with zero quality defects.'
Estimated compensation for this role type in India is ₹2,40,000 - ₹3,80,000 per annum (Fresher analyst). The actual salary package offered depends on factors such as company size, work mode (remote or on-site), individual technical proficiency, and negotiations during final HR rounds.
Key credentials: GMP Certified Professional (ASQ), Certified Clinical Research Coordinator (CCRC), or specialized laboratory training certificates in high-performance liquid chromatography (HPLC) and safety standards.
Frequently Asked Questions
❓ Frequently Asked Questions (FAQs)
Q1. What is the job role offered by Novotech?
A: Novotech is hiring for the Clinical Data Programmer I (SDTM) position in India.
Q2. What qualifications are required for this role?
A: Candidates should have a Bachelor’s Degree in Life Sciences, Computer Science, Mathematics, Statistics, or another Quantitative/Analytical discipline.
Q3. Is prior experience required?
A: Yes. Candidates should have SAS Programming experience and relevant experience in SDTM Programming, preferably in a pharmaceutical company, CRO, or a related clinical research environment.
Q4. What are the primary responsibilities of a Clinical Data Programmer I?
A: Responsibilities include SDTM programming, CRF annotation, quality control, Define.xml preparation, reviewer guide development, regulatory submission support, and maintaining study documentation.
Q5. Which technical skills are important for this position?
A: Candidates should have knowledge of SAS Programming, SDTM, Clinical Protocols, Statistical Analysis Plans (SAP), CDISC standards, and Define.xml.
Q6. Is this role suitable for freshers?
A: The job description indicates that relevant SAS Programming and SDTM experience is preferred, making it more suitable for candidates with prior industry experience.
Q7. What type of company is Novotech?
A: Novotech is a global full-service Clinical Research Organization (CRO) providing clinical research and scientific advisory services across Asia-Pacific, Europe, and the United States.
Q8. What career opportunities does this role provide?
A: This position offers exposure to global clinical trials, regulatory submissions, clinical data standards, and career growth in Clinical Data Programming and Biostatistics.
Q9. What employee benefits does Novotech offer?
A: Novotech offers flexible working options, wellness programs, paid parental leave, professional development opportunities, mentorship programs, and an inclusive work environment.
Q10. How can I apply for this position?
A: Interested candidates can submit their application through JobPortalConnect in the How to Apply section of the job post.
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