Associate Director Biostatistics

Biometrics South San Francisco, California Bothell, Washington


Description

Associate Director of Biostatistics

 

Summary: 

Provide biostatistical support and leadership for the statistical strategy, oversee and contribute to the implementation, development, and analysis methodologies in the health technology assessment (HTA) activities across Seagen development programs. In addition to the HTA responsibility, may provide statistical/strategic inputs to the clinical development plans while supporting clinical trials within a program. Contribute to clinical protocols for statistical concept as well as broader drug development concepts. Perform or oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and scientific community. Ensure adherence to regulatory and company standards. May manage and develop reports and oversee their work projects.  

 

Responsibilities: 

  • Provide biostatistical support and leadership to health technology assessment (HTA), collaborate with Seagen HEOR and clinical team to develop HTA strategy and support submissions.  
  • May provide leadership to the biometrics team on one or more clinical programs or key studies;
  • Provide update to management on HTA and program progress with focus on biometrics
  • Collaborate with medical monitors and other study personnel on the creation of clinical development plans and clinical trial designs
  • Perform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of a design
  • Design and write statistical sections for clinical trial protocols or oversee this work
  • Generate study randomization and provide inputs on maintaining study blinding
  • Develop statistical analysis plans for HTA analysis and clinical trials or oversee this work
  • Write statistical sections of regulatory submissions or oversee this work
  • Design and conduct statistical analysis of clinical data or oversee this work
  • Work with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staff
  • Represent Seattle Genetics statistical position to regulatory agencies
  • Key contributor in project planning
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
  • Become knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)
  • Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
  • May manage reports, oversee their work based on level of experience, and provide coaching and mentoring on an individualized basis for career development


Qualifications:

  • PhD with 6+ yrs of experience (or Master with 8+ yrs of experience) as a program lead statistician for early or late phase programs
  • Previous experience providing leadership to biometrics staff within a clinical team
  • Knowledge and experience to exercise independent judgment and provide oversight to programmers, data managers, and junior statisticians
  • Previous experience supporting HTA submissions
  • Excellent communication and presentation skills, both written and verbal
  • Knowledge of FDA regulations, ICH guidelines, the drug development process
  • Proficiency with SAS® procedures and programming language

Preferred Qualifications:

  • Strong technical knowledge and research skills
  • Proficiency with R programming
  • Oncology clinical trial experience
  • Experience with innovative trial designs