Director, Biostatistics

Instil Bio is seeking an experienced and highly motivated Director, Biostatistics. This position will provide statistical guidance and support in all clinical trials of the company studying Tumor-infiltrating lymphocytes (TIL) therapies in patients with advanced solid tumors, with a focus on the analyses of translational medicine data, including but not limited to pharmacokinetic, pharmacodynamic, and biomarker data. The successful candidate will collaborate with the translational medicine scientists, clinician, data management, as well as other internal clinical study team functions and external vendors. This individual will work alongside statistical programmers, write statistical analysis plans, perform statistical analysis, contribute to clinical study reports and PK-PD reports, present results summarizing findings, develop publications of clinical trial results, and contribute to the overall clinical development plan. The successful candidate will participate in regulatory submissions and develop responses to regulatory queries. The candidate will directly contribute to the company success by increasing the strength of study designs, interpretability of results, regulatory strategy and interactions, translational medicine strategies and by implementing appropriate statistical methods to facilitate product development.

Responsibilities include but not limited to:

  • Author statistical analysis plans and lead the execution of translational medicine data analyses including summarization of PK, PD data and correlative analyses with clinical efficacy and safety data
  • Conduct additional exploratory analyses of PK, PD, biomarker data, and product characteristics data, together with patient characteristics data and clinical outcomes data for hypothesis generation and signal finding
  • Collaborate with cross-functional study teams in data collection and review, data analysis and reporting
  • Provide oversight and guidance to stats and programming team members and vendors to assure quality of analysis deliverables
  • Appropriately adopts or develops innovative statistical methods to solve scientific questions, in support of clinical development decision making and product or process improvements
  • Responsible for drafting and finalizing mockup TFLs for planned and adhoc analyses of translational medicine data from multiple clinical trials
  • Support and participate in the preparation of study reports, PK-PD and other relevant technical reports for regulatory submissions
  • Perform and/or validate statistical analysis to support publications and conference presentations


  • PhD in biostatistics or statistics with a minimum of 10 years relevant experience in the biotechnology/pharmaceutical industry. MS may be considered with extended relevant experience. Experience in cell therapy or immuno-oncology therapeutics preferred
  • Excellent interpersonal skills with strong verbal/written communication skills
  • FDA and EMA submission experience
  • Strong understanding of CDISC standards/implementation guides
  • Proficient with standard statistical software including SAS and R
  • Ability to work independently and collaboratively on multiple projects, anticipate challenges and defend positions based on science and sound data analysis
  • Excellent analytical and problem-solving skills with a keen understanding of statistical principles and concepts
  • Statistical expertise and experiences in PK/PD, biomarker, and discovery data analysis methodologies a plus