Posted to MedZilla on 5/29/2017


Takeda Pharmaceuticals

US-MA, Director / Associate Director of Biostatistics, Biomarker 1602019-MZ


 
 

OBJECTIVES:

  • Serve as global statistical expert and provide strategic inputs on personalized and precision medicine, translational research and biomarker-related drug development activities
  • Champion and promote innovative designs and optimal development plan for biomarker-related studies
  • Strategize and oversee all biomarker-related statistical support
  • Establish and drive strategy on resource, processes and standards
  • Provide insight and continual research into future direction of biomarker statistics

ACCOUNTABILITIES:

  • Lead development of short and long-range strategies and goals for biomarker statistics group
  • Serve as an advisor to cross-functional leadership on biomarker strategy
  • Partner with cross-functional key stakeholders to maximize statistical contributions to biomarker, clinical, regulatory, and commercial development strategies
  • Ensure adequate statistical support for biomarker-related development projects and timely delivery of statistical deliverables
  • Oversee all biomarker statistics resource needs and quality issues
  • Develop and retain statistical talents in the group
  • Champion and promote innovative designs and efficient analysis methodologies in biomarker-related studies
  • Ensure productive collaborations with other functions supporting biomarker-related activities
  • Provide statistical leadership and support for regulatory meetings, submissions and follow up on biomarker-related activities
  • Keep the group current on statistical methodologies relating to drug development and regulatory requirements
  • Build and maintain a good network with external statistical experts
  • Create and lead initiatives and activities in external professional organizations to identify best practice and its applicability in Takeda.

Qualifications

EDUCATION, EXPERIENCE AND SKILLS:

  • PhD or MS in Statistics or Biostatistics
  • 10+ years of pharmaceutical/biotech experiences with a PhD degree and 12+ years with an MS degree
  • 5+ years of line management experiences
  • Advanced and comprehensive knowledge of biomarker-assisted clinical study designs, analysis methodology and data interpretation across theurapeutic areas
  • Advanced and comprehensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of biomarker-assisted clinical trials and regulatory submissions across theurapeutic areas
  • Excellent technical skills
  • Outstanding communication skills
  • Excellent inter-personal and people management skills
  • Strong leadership and influencing skills
  • Ability to deal with conflict
  • Experience representing statistics in interactions with regulatory agencies a plus

TRAVEL REQUIREMENTS:

  • Access to transportation to attend various meetings held in proximity to the Takeda offices.
  • Able to fly to various meetings at investigator, vendor or regulatory agency sites.
  • Some international travel may be required



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Schedule


Please visit our website at takedajobs.com

 
 


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