Senior Biostatistician for Clinical Trial | On-site | Hyderabad | Contract

1 week ago

Hyderabad Telangana India, Telangana IndusGuru Network Partners Full time

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.

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