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Principal Biostatistician FSP - Translational Medicine

CytelPune🇮🇳India

Quick overview

SeniorityLeader
Employment typeFull Time
Work modeHybrid
LocationPune, India
Clinical ResearchClinical TrialsDeep LearningPythonMachine LearningData Analysis

Job description

Who Are You?
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead early development clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same. 
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

As a Principal Biostatistician, your responsibilities will include:

  • Provide statistical expertise and support for translational medicine and translational clinical oncology projects across various stages of drug development.
  • Develop statistical analysis plans (SAPs), analysis specifications, and statistical methodologies for translational research and clinical oncology studies.
  • Design and analyze biomarker-driven studies, including exploratory, predictive, prognostic, pharmacodynamic, and pharmacogenomic biomarker analyses.
  • Support early-phase oncology clinical trials, including Phase I and Phase II studies, dose-escalation and dose-expansion cohorts, and proof-of-concept studies.
  • Perform statistical analyses of clinical, molecular, genomic, proteomic, and other translational datasets.
  • Collaborate with clinical and translational scientists to identify relevant endpoints, define analysis populations, and establish appropriate statistical approaches.
  • Apply statistical methods to investigate relationships between biomarkers, treatment response, safety, efficacy, and clinical outcomes.
  • Support the integration and interpretation of clinical data with translational research findings to inform drug development decisions.
  • Contribute to the development and review of statistical analysis plans, study protocols, data review plans, and clinical study documentation.
  • Conduct exploratory data analysis, hypothesis testing, regression modeling, survival analysis, and other relevant statistical analyses.
  • Support patient stratification, subgroup analyses, enrichment strategies, and precision medicine approaches in oncology development programs.
  • Interpret statistical results and communicate findings through technical reports, presentations, data visualizations, and scientific publications.
  • Ensure statistical deliverables meet applicable quality standards, study requirements, and relevant regulatory and industry guidelines.
  • Work closely with biostatistics, clinical data management, bioinformatics, biomarker, and programming teams to ensure data quality and consistency of analytical outputs.
  • Contribute to scientific discussions, study design reviews, and cross-functional decision-making throughout the clinical development lifecycle.

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

  • Master's or Ph.D. in Statistics, Biostatistics, Applied Mathematics, Data Science, or a related quantitative discipline.
  • Relevant experience in biostatistics or statistical analysis within pharmaceutical research, biotechnology, clinical research, or drug development.
  • Experience supporting translational medicine, translational research, or clinical oncology development programs.
  • Strong understanding of statistical principles and their application to clinical trials and biomarker research.
  • Experience developing statistical analysis plans and performing analyses of clinical or translational research data.
  • Proficiency in statistical programming tools such as R, SAS, or Python.
  • Knowledge of clinical trial design, oncology endpoints, biomarker analysis, and exploratory statistical methods.
  • Ability to interpret complex datasets and translate analytical results into meaningful scientific insights.
  • Strong communication, documentation, problem-solving, and cross-functional collaboration skills.

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