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Job Detail 
Job Detail

Job Summary
Senior Director, Biostatistics
Job Code: 6191BR
POSTED: Oct 30
Salary: Open Location: Cambridge, Massachusetts
Employer: www.millennium.com Type: Full Time - Experienced
Category: Biometrics/biostatistics    



Employer Information
About www.millennium.com

Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world – one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

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Job Description
Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world – one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Play a leading role in establishing an influential statistics unit within the biostatistics department to provide statistical support to Global Medical Affairs (GMA) and Health Economics and Outcomes Research (HEOR). Provide statistical consultation and analytical support to GMA and HEOR and contribute to the overall strategies in positioning the company products. Design and oversee post-marketing trials and review investigator-initiated trials. DUTIES & RESPONSIBILITIES Develop or apply efficient statistical methodologies to support value proposition of company products.

Be responsible for the statistical components of HEOR projects.

Ensure the appropriate incorporation of HEOR endpoints into late phase trials that meets the requirements of the regulatory and reimbursement agencies in key global markets.

Design and serve as the lead statistician for post-marketing trials.

Review investigator-initiated trials.

Provide statistical consultation and analytical support to GMA, HEOR, and Commercials.

Contribute to overall strategies in positioning the company products.

Support “HEOR-heavy” protocols and be responsible for analysis plans for HEOR endpoints.

Partner with HEOR scientists to design and develop HEOR research projects.

Perform statistical programming for advanced statistical methodologies.

Keep updated with regulatory and global reimbursement requirements.

NOTES: International Candidates Will Be Considered


Requirements
QUALIFICATIONS Extensive knowledge on HEOR models and statistical methodologies.

Statistical expertise on post-marketing clinical trial designs.

Profound understanding of global reimbursement and regulatory requirements on oncology drugs.

Demonstrated ability of developing novel statistical methodologies in HEOR with a track record of publications in peer-reviewed journals.

Familiar with HEOR research project development processes.

Successfully completed a few post-marketing and HEOR projects.

Work effectively in a cross-functional environment.

Strong communication and interpersonal skills.

Good statistical programming skills using SAS and other statistical software. YEARS EXPERIENCE More than 5 years


 

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