Director / Associate Director of Biostatistics, Biomarker job – Takeda Pharmaceuticals – Cambridge, MA

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 statisti

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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

we are driven to improve people’s lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visit

http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

Schedule

About secureteam

secureteam
A Computer Programmer whose articles got mentions from the likes of The New York Times, Kissmetrics and AllTopStories. He writes articles, novels and poems; spends most of his time reading everything he could get his hands on. He is currently pursuing his Masters from The University of Illinois and holds a Bachelors in Electronics Engineering from the University of California. He is a programmer, a motivational writer and speaker.

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