Pharmaceutical Biostatistician@ Ironwood Pharmaceuticals
United States
Masakazu (Sho) Ando
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Tokyo University of Science
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FlashIntel GPTMasakazu (Sho) Ando is a highly experienced biostatistics expert with over 32 years of work experience. He has expertise in clinical trials, regulatory submissions, oncology, and SAS. Based in the United States, Masakazu has worked with the FDA and internal partners to assist Asian-based firms in implementing drug products through the full life cycle development process. He excels in providing data outlining how products will meet NDA requirements and optimize value to patients and corporate portfolio. Masakazu has a strong track record of spearheading initiatives in clinical research projects and implementing effective negotiations and communications.
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About
Broad Therapeutic Expertise with Statistical & Data Management in Asian & US MarketsBiostatistician who has worked successfully with the FDA and internal partners to assist Asian-based firms take drug products through the full life cycle development process in the US. Provides data outlining how product will meet NDA requirements and optimize value to patients and the corporate portfolio. Spearheads initiatives in clinical research projects for all trial phases. Strategizes with scientists, data management, clinical operations and global regulatory bodies to surpass corporate objectives for boutique CROs and global drug development firms.Specialties: Research & Clinical Study Project Management | Key Opinion Relationship Development | Statistical Programming & Reporting | Effective Negotiations & Communications | Vendor Relations & Management | FDA Applications & Approvals | CRO and Vendor Selection & Oversight | Timeline & Budget Development Infrastructure Development & Planning | Statistical & Clinical KOL Relationships
...See MoreWork Experience
Pharmaceutical Biostatistician
Vice President Head Of Data Science
Biotechnology Research
Masakazu (Sho) Ando's Professional Milestones
- Statistical Regulatory Submissions Specialist, Team Lead (2006-10-01~2009-12-01): Streamlined regulatory submission processes, improving efficiency and accuracy for regulatory submissions.
- Director Biostatistics (2012-02-01~2022-08-01): Developed cutting-edge biostatistics technologies to advance scientific discoveries and drive informed decision-making.
Education
Management Science
Skill
Biostatistics
Clinical Trials
Regulatory Submissions
Oncology
Sas
Statistical Programming
Data Analysis
Cro
Clinical Development
Clinical Study Design
Certification
Colleagues
Andrew Davis
Chief Business Officer | Board Member
John Minardo
Chief Legal Officer
John Minardo
Chief Legal Officer
Jason Rickard
Chief Operating Officer
Sravan K. Emany
svp chief financial officer at ironwood pharmaceuticals
Other Named Masakazu (Sho) Ando
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Masakazu (Sho) Ando's social media include: Linkedin,
Masakazu (Sho) Ando works for Ironwood Pharmaceuticals
Masakazu (Sho) Ando's role in Ironwood Pharmaceuticals is Pharmaceutical Biostatistician
Masakazu (Sho) Ando works in the industry of Biotechnology Research
Masakazu (Sho) Ando's colleagues are Andrew Davis,John Minardo,John Minardo
Masakazu (Sho) Ando's latest job experience is Pharmaceutical Biostatistician at Ironwood Pharmaceuticals
Masakazu (Sho) Ando's latest education in Tokyo University of Science
