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
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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