Posted to MedZilla on 10/23/2017


Takeda Pharmaceuticals

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


 
 

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director/Associate Director of Biostatistics Biomarker in our Cambridge, MA office.

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.

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
WHAT TAKEDA CAN OFFER YOU:
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.
#LI-JD1



Schedule


Please visit our website at takedajobs.com

 
 


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