The client is setting up a Clinical trial team for their global cell and gene therapy trial . As part of this, we are looking to hire a couple of senior biostatisticians with relevant experienceThe ideal
candidate will have strong expertise in statistical methodologies, biostatistics, and clinical
data analysis, with the ability to design and implement statistical models to support clinical
research and development.
Key Responsibilities :
▪ Lead statistical design, analysis, and reporting activities for clinical trials and
research studies.
▪ Collaborate with cross-functional teams including clinical, medical, regulatory,
and data management to ensure appropriate statistical input in study
protocols, SAPs (Statistical Analysis Plans), and CRFs.
▪ Perform advanced statistical modeling, including prognostic modeling and data
interpretation, to support clinical decision-making.
▪ Ensure statistical deliverables are of high quality, accurate, and aligned with
regulatory standards (FDA, EMA, ICH, etc.).
▪ Mentor junior biostatisticians and provide technical guidance across multiple
studies / projects.
▪ Contribute to publications, regulatory submissions, and presentations of study
results.
▪ Stay updated with latest statistical methodologies, tools, and regulatory
guidance in biostatistics.
Requirements :
▪ Master’s or PhD in Biostatistics, Statistics, or a related quantitative discipline.
▪ 6–8 years of hands-on experience in biostatistics within pharmaceutical, biotech, or
CRO industry.
▪ Strong expertise in statistical modeling, clinical trial methodology, and data
interpretation.
▪ Proficiency in statistical programming languages (SAS, R, Python) with ability to
independently perform statistical analyses.
▪ Deep understanding of regulatory requirements and statistical principles applied to
clinical development.
▪ Excellent problem-solving, analytical, and communication skills.
▪ Ability to manage multiple projects, prioritize deliverables, and work in a fast-paced
environment.
Skills :
▪ Experience with adaptive trial designs, Bayesian methods, or real-world evidence
analysis.
▪ Knowledge of data visualization and reporting tools.
▪ Previous mentoring or leadership experience in statistical teams.
Senior Data Scientist • Hyderabad, Republic Of India, IN