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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