Principal Biostatistician

Date: Mar 15, 2023

Location: US

Company: Cytel Software Corporation

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!

Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.


We are hiring a Principal Biostatistician in our drug discovery team. You are guaranteed to be a vital contributor to everyone’s success, most importantly your own.  You will be empowered and will have the opportunity to serve as a scientific leader who will provide statistical leadership in the design, analysis, and interpretation of clinical and translational studies at both the compound and therapeutic areas (TA) levels, promoting innovative designs and methodologies. 


How you will contribute:

  • Drives all statistical aspects of biomarker development for R&D assets for Oncology Cell Therapy and TA covering design and analysis from pre-clinical to early clinical studies.
  • Drives data-driven decision-making in a multidisciplinary team environment (comprising of preclinical, biomarker, translational, and clinical scientists, computational biologists, and quantitative pharmacologists) by providing a high level of statistical rigor to the analyses and interpretation of complex data generated by translational teams.
  • Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, and cross-study analyses including statistical methodology, interpretations, regulatory submissions, and follow-up.
  • Establishes and drives Oncology Cell Therapy and TA programs' functional strategy for resources, processes, and standards to maximize efficiency and global data integration.
  • Participates in functional and cross-functional initiatives including process and quality improvements.
  • Serve as global statistical lead for biomarker development in Oncology Cell Therapy and TA. Provide statistical leadership and support for internal decision-making, regulatory meetings, submissions, and follow-up.
  • Review key program documents and presentations (portfolio entry document, PRC narratives, biomarker strategy plan), attend Translational Research meetings to develop a comprehensive overview of the existing data in pre-clinical and translational studies, form a deep understanding of the development rationale and strategy, and the key questions that need to be answered from biomarker data and help the teams identify any statistical shortfalls and propose solutions to overcome them
  • Attend scientific conferences (AACR, ASCO, SITC) and stay abreast with the latest developments in IO and cell therapy space with an eye towards acquiring biomarker data that can help augment internal data
  • Play a leadership role in the development of Exploratory Analysis Plans and completion of major statistics deliverables and milestones in collaboration with other functions
  • Stay up-to-date on emerging technologies and associated data analytic techniques, external databases, and novel methodologies that can help the team derive the maximum value out of the biomarker data
  • Drive/participate in the development and implementation of global systems, processes, and standards to maximize quality and efficiency.
  • Leverage standardized analysis methods and reporting standards to maximize global data integrability; identifies best practice for utilization across programs. 
  • Provide or identify internal and external statistical expertise and capacity to support development activities. Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality. Assess, communicate, and propose solutions for internal, external resource, and/or quality issues that may impact deliverables/timelines at the program level. Provide input for planning and management of external budgets related to statistical deliverables.
  • Active participation in external professional initiatives and organizations to identify industry best practices and their applicability in our client.



  • Ph.D. in statistics/biostatistics or in bioinformatics with an emphasis on statistics with at least 5 years of relevant industry experience or MS in statistics with at least 8 years of relevant industry experience
  • Teamwork is key for this role. The candidate will be expected to routinely interface with other quantitative functions in the industry and must have strong interpersonal and people management skills, and the ability to influence others, without direct hierarchical authority, to affect change across organizational boundaries.
  • Expert knowledge across broad areas of statistical methodologies including subgroup analysis, longitudinal data analysis, multivariate methods, predictive modeling, machine learning, and Bayesian modeling. Strong background in statistical modeling in R or SAS with the ability to independently code relevant programs.
  • Expert knowledge of statistical approaches for assays, and biomarker development and validation.
  • Advanced knowledge of the pharmaceutical industry, and overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
  • Excellent oral and written communication skills.
  • Strong project management skills.
  • Knowledge of IO Biology and experience working with raw data from emerging biomarker technology platforms in the space (CyToF, TCRSeq, Multiplexed IHC) is a plus 


What’s in it for you:

  • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development.
  • You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to learn and grow your career.
  • Work with and leverage the best and brightest minds in the industry.