Job Title: Biostatistician

Location: Noida
Employment Type: Permanent, Full-time
Experience: Minimum 2 years
Industry: Clinical Research / Contract Research Organization (CRO) / Pharmaceutical / Biotechnology.
Working Days: 5.5 days per week (2nd & 4th Saturdays off)
Office Timing: 9:00 AM 5:30 PM

About the Role

We are looking for a skilled and detail-oriented Biostatistician to join our team within the Clinical Research industry. The ideal candidate will have hands-on experience in clinical research, statistical analysis, clinical trial data management, and regulatory requirements.

The selected candidate will provide statistical support throughout the clinical trial lifecycle, ensuring data quality, accuracy, regulatory compliance, and timely project delivery.

Key Roles & Responsibilities

- Provide statistical inputs to Case Report Forms (CRFs), annotation lists, and Data Validation Plans.
- Review and provide statistical inputs for Tables, Listings, and Graphs (TLGs) and Clinical Study Reports (CSRs).
- Prepare sample size calculations and statistical justifications.
- Provide statistical inputs to clinical trial protocols.
- Prepare randomization schedules, Statistical Analysis Plans (SAPs), and analysis datasets.
- Support clinical trial data collection activities, including review and entry of clinical trial data into study databases.
- Participate in data cleaning, validation, and quality review activities to ensure data integrity and accuracy.
- Perform data validation and prepare data deviation lists prior to statistical analysis.
- Support discrepancy management and comprehensive clinical data review.
- Conduct Serious Adverse Event (SAE)



reconciliation and support safety data review.
- Coordinate with Data Management teams on study-specific requirements.
- Collaborate with Medical Writing teams to support statistical analysis, interpretation, and clinical reporting.
- Prepare and review weekly project/status reports as required.
- Provide statistical support throughout the clinical study lifecycle.
- Ensure timely completion of assigned activities while maintaining high standards of quality.
- Participate in client communication and project-related discussions as required.

Educational Qualifications

- B.Sc. / M.Sc. in Statistics, Biostatistics, or a related field.
- Ph.D. in Statistics/Biostatistics will be an added advantage.
- Minimum 2 years of relevant experience in Clinical Research, CRO, Pharmaceutical, Biotechnology, or a related industry.

Desired Skills

- Good understanding of clinical trials and clinical research processes.
- Knowledge of statistical concepts and their application in clinical research.
- Familiarity with SAPs, TLGs, CRFs, clinical databases, and analysis datasets.
- Understanding of clinical data validation and reconciliation processes.
- Strong analytical and problem-solving skills.
- Valuable attention to detail and commitment to data quality.
- Ability to work effectively with cross-functional teams including Data Management, Medical Writing, Clinical Operations, and Pharmacovigilance.
- Good written and verbal communication skills.
- Ability to manage multiple activities and deliver projects within timelines.

If interested then please share your resume on this Mail id- [email protected]

You can also call me (phone hidden)(Poornima)

📌 Biostatistician || Clinical Research Industry || Noida
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