Principal Biostatistician
IQVIA
Date: 1 week ago
City: Thāne, Maharashtra
Contract type: Full time
Remote

Summary
The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for discovery, manufacturing, research, development, and/or marketed product needs with minimal supervision. The role supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents Statistics for cross-functional teams or working groups.
The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for discovery, manufacturing, research, development, and/or marketed product needs with minimal supervision. The role supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents Statistics for cross-functional teams or working groups.
- Independent study execution experience
- Recent oncology experience (Solid tumors, hematology malignancies)
- Study start-up experience.
- Regulatory submission experience
- Experience in quality assurance for TLFs, important ADaM datasets, and endpoint derivations. Hands-on QC or validation using SAS or R.
- Strong skills in collaborating with other functions (clinical, data management, regulatory)
- Ability to operate as an independent study statistician for multiple studies.
- Ph.D. in Statistics or related field with minimum 3 years relevant experience, or Master’s in Statistics or related field with minimum 5 years of relevant experience.
- Proficient in SAS or R programming.
- Good written, oral, and interpersonal communication skills.
- Ability to work independently.
- Demonstrated ability to work in interdisciplinary contexts outside statistics
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