Principal Biostatistician

Location

Hyderabad | India

Job description

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.

sas,r,clinical trials,fsp,communication,collaboration,biostatistics,quality assurance,statistical analysis

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