Job Title: Principal Biostatistician
Location: Hyderabad
Job Type: FullTime
Key Responsibilities:
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 CrossFunctional 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 FullService Provider (FSP) and clientfacing 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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