Principal Biostatistician
Location
Secunderabad | India
Job description
About the Role:
The Principal Biostatistician will be responsible and accountable for the statistical activities and support on statistical solutions for studies/publications and conferences. Support the tasks independently seeking peer inputs/ reviews which includes protocol development in alignment with the development plan, providing inputs on statistical scientific and operational aspects of the planning, sample size estimation, design and reporting of trials/experiments, and production and delivery of statistical deliverables and exploratory analyses.
Ensure that documents, specifications, programs/macros are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for Interventional and Non-Interventional Clinical studies.
Maintain efficient interfaces with other statisticians, internal and external customers, CROs and CPOs as needed.
Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
Key Responsibilities:
Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
Excellent knowledge of/experience with SAS/ R/ Splus or any other business or research analytic software with an expertise in at least one software.
Good understanding of global clinical trial practices, procedures, methodologies and deep knowledge of data architecture
Statistical and numerical knowledge and expertise in analytic aspects and applications in clinical trials.
Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.
Good understanding of drug development, regulatory requirements, ICH and HA guidelines
Role Requirements
Essential Requirements:
Education: MS/ MSc (in Statistics or equivalent) with 8+ years relevant work experience or PhD (in Statistics or equivalent) with 5+ years of work experience.
Good communication and presentation skills
Desirable Requirements:
Pharmaceutical industry domain knowledge
Job tags
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