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Principal Biostatistician


EMentor Enterprises Private Limited


Location

Secunderabad | India


Job description

1. Biostatistical Analysis and Strategy:

- Develop statistical analysis plans for clinical trials.

- Collaborate with clinical teams to design studies and determine primary endpoints.

2. Statistical Methodology:

- Apply advanced statistical methodologies for data analysis.

- Ensure appropriate implementation of statistical techniques.

3. Regulatory Compliance and Documentation:

- Maintain compliance with global regulatory standards (FDA, EMA, etc.) in statistical analysis.

- Prepare statistical sections of regulatory submission documents.

4. Data Interpretation and Reporting:

- Interpret statistical results in the context of clinical trials.

- Generate comprehensive reports and present findings to stakeholders.

5. Collaboration with Cross-Functional Teams:

- Work closely with Data Management and Clinical Operations teams.

- Provide statistical input during the data collection and analysis phases.

6. Project Management:

- Manage biostatistical aspects of multiple clinical trials.

- Ensure timely delivery of statistical outputs.

7. Client Engagement and Communication:

- Act as a statistical consultant for clients and internal teams.

- Communicate complex statistical concepts in an understandable manner.

8. Quality Assurance:

- Perform quality control of statistical analyses and outputs.

- Ensure the accuracy and reliability of statistical deliverables.

9. Professional Development and Knowledge Sharing:

- Stay updated with the latest statistical techniques and industry trends.

- Participate in and contribute to professional forums and conferences.

Qualifications:

Education:

- Master s or PhD in Biostatistics, Statistics, or a related field.

Experience:

- Proven experience in biostatistics, preferably in clinical trials for more than 10 years.

- Familiarity with Full-Service Provider (FSP) and client-facing environments.

Skills:

- Excellent analytical skills and proficiency in statistical software (SAS, R, etc.).

- Strong communication and collaboration abilities.

- Capable of translating statistical findings into actionable insights.

Additional Requirements:

- Ability to work both independently and collaboratively.

- Adaptability to changing requirements and deadlines.

- Committed to ongoing professional growth and development.


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