Principal/Sr. Principal Biostatistician - Bothell, WA | Biospace
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Principal/Sr. Principal Biostatistician

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
8/14/2017
Position Type:
Full time
Job Code:
1859
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Summary:

This position will report to Associate Director, Biostatistics and provide leadership to the biometrics team (programming, data management, statistics) and statistical/strategic input into the clinical development plans while supporting all clinical trials within a program. The successful candidate will be a key contributor to clinical protocols for statistical concept as well as broader drug development concepts, perform or oversee performance of analyses of clinical trial data, provide statistical interpretation of results, and will collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community while ensuring adherence to regulatory and company standards.  This position could manage biostatisticians (fulltime and/or contractor), oversee their work based on their level of experience, and provide coaching and mentoring on an individualized basis for career development.

Responsibilities:

   
        
  • Provide leadership to the biometrics team (data management, programming, statistics) on a given clinical program, group of programs, or key study(ies); review work of statisticians supporting this work
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  • Provide update on program progress with focus on biometrics to management
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  • Collaborate with Medical Directors and other study personnel on the creation of clinical development plans and clinical trial designs
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  • Perform or oversee performance of power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of designs
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  • Provide statistically sound experimental design and data analysis input to meet project objectives and regulatory (e.g. FDA) requirements
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  • Design and write statistical sections for clinical trial protocols or oversee this work
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  • Generate study randomizations and provide input on maintaining study blinding
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  • Design and write statistical analysis plans for clinical trials or oversee this work
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  • Write statistical sections of regulatory submissions or oversee this work
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  • Design and conduct statistical analysis of clinical data or oversee this work
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  • Work with medical monitors to develop ad hoc analysis plans and perform analyses or ensure analyses are performed appropriately by programming staff
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  • Represent Seattle Genetics statistical position to regulatory agencies
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  • Key contributor in project planning (timelines, etc.) with clinical, regulatory and data management
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  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
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  • Become knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)
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  • Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
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  • Knowledge of FDA regulations, ICH GCP guidelines, the drug development process
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Requirements


Qualifications:

  • Principal: MS with 6+ yrs or PhD with 4+ yrs/study stat with high independency for complicated studies
  • Sr. Principal: MS with 8+yrs or PhD with 6+ yrs/ Program Lead Stat for early programs or pivotal studies for late programs
  • Previous experience providing leadership to biometrics staff within a clinical team
  • Knowledge and experience to exercise independent judgment and provide indirect oversight to programmers, data managers, and more junior statisticians.
  • Excellent communication and presentation skills, both written and verbal
  • Sound understanding of ICH guidelines and FDA requirements
  • Proficiency with SAS® procedures and programming language

Preferred:

  • Submission experience a plus
  • Strong simulations experience/skills
  • Oncology experience preferred
  • Proficiency with S-Plus or R a benefit