Mitsubishi Chemical Group
Director, Biostatistics
Mitsubishi Chemical Group, Jersey City, New Jersey, United States, 07390
Mitsubishi Chemical Group - Director, Biostatistics
Location:
Jersey City, New JerseyEntrepreneurial Spirit, Rooted in Tradition . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which has a storied reputation of over 300 years. Our parent company is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with a global reach.The Director, Biostatistics is a leadership role responsible for managing biostatistics activities and for the development and ongoing operation of the company's tools, technologies, and technical solutions leveraging data science, advanced analytics, machine learning, and other algorithms to support clinical development activities.Responsibilities
Responsible for statistical planning and execution of multiple clinical trials.Provide expertise for clinical trial design, SAP, and all trial-related documents requiring Biostatistics knowledge.Support the development and execution of biostatistics, statistical programming, and data management strategies.Provide statistical leadership into ongoing clinical trial programs and the development of new programs.Ensure quality and timeliness of statistical, programming, and data management deliverables.Support interactions with global health authorities and partner contract research organizations as needed.Accountable for the accuracy of statistical analyses and proposals for health authority meetings.Provide resources and support for analytical activities for scientific publications.Collaborate closely with members of the Statistical Programming, Data Management, and Medical Writing organizations.Establish and ensure adherence to biostatistics and statistical programming best practices, SOPs, standards, and processes.Collaborate with and oversee the work of external service providers involved in the drug development process.Qualifications
Doctoral degree in Biostatistics/Statistics preferred.10+ years in the biotech/pharmaceutical industry with increasing biostatistics responsibilities.Experience with multiple (s)NDAs, BLAs, MAAs required; J-NDA experience is a plus.Experience in multiple therapeutic areas and innovative Phase II clinical study designs for rare/uncommon disorders.Demonstrated record of fostering creativity, productivity, execution with urgency, teamwork, and accountability.Team-builder who leads by example and encourages collaboration across departments.Comfort with model-based and agile drug development; appreciation for observational methodologies preferred.Ability to articulate complex methodologies to senior executives.Up to 20% domestic and international travel required.Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit of a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. MTP offers unparalleled opportunities for career success and a supportive level of employee benefits.MTP provides a competitive benefits package, including Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance, and additional voluntary benefits. We provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on the hire date.The salary range for this position is $160,000 - $235,000, influenced by factors such as the scope of responsibilities, candidate's experience, education/training, job-related skills, and market considerations.This position is eligible to participate in our annual Short-Term Incentive (STI) program and Long-Term Incentive (LTI) program, with specific information provided upon hire.Job Locations:
US-NJ-Jersey CityJob ID:
2024-1887# of Openings:
1Category:
Data Science & Medical WritingAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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Location:
Jersey City, New JerseyEntrepreneurial Spirit, Rooted in Tradition . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which has a storied reputation of over 300 years. Our parent company is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with a global reach.The Director, Biostatistics is a leadership role responsible for managing biostatistics activities and for the development and ongoing operation of the company's tools, technologies, and technical solutions leveraging data science, advanced analytics, machine learning, and other algorithms to support clinical development activities.Responsibilities
Responsible for statistical planning and execution of multiple clinical trials.Provide expertise for clinical trial design, SAP, and all trial-related documents requiring Biostatistics knowledge.Support the development and execution of biostatistics, statistical programming, and data management strategies.Provide statistical leadership into ongoing clinical trial programs and the development of new programs.Ensure quality and timeliness of statistical, programming, and data management deliverables.Support interactions with global health authorities and partner contract research organizations as needed.Accountable for the accuracy of statistical analyses and proposals for health authority meetings.Provide resources and support for analytical activities for scientific publications.Collaborate closely with members of the Statistical Programming, Data Management, and Medical Writing organizations.Establish and ensure adherence to biostatistics and statistical programming best practices, SOPs, standards, and processes.Collaborate with and oversee the work of external service providers involved in the drug development process.Qualifications
Doctoral degree in Biostatistics/Statistics preferred.10+ years in the biotech/pharmaceutical industry with increasing biostatistics responsibilities.Experience with multiple (s)NDAs, BLAs, MAAs required; J-NDA experience is a plus.Experience in multiple therapeutic areas and innovative Phase II clinical study designs for rare/uncommon disorders.Demonstrated record of fostering creativity, productivity, execution with urgency, teamwork, and accountability.Team-builder who leads by example and encourages collaboration across departments.Comfort with model-based and agile drug development; appreciation for observational methodologies preferred.Ability to articulate complex methodologies to senior executives.Up to 20% domestic and international travel required.Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit of a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. MTP offers unparalleled opportunities for career success and a supportive level of employee benefits.MTP provides a competitive benefits package, including Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance, and additional voluntary benefits. We provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on the hire date.The salary range for this position is $160,000 - $235,000, influenced by factors such as the scope of responsibilities, candidate's experience, education/training, job-related skills, and market considerations.This position is eligible to participate in our annual Short-Term Incentive (STI) program and Long-Term Incentive (LTI) program, with specific information provided upon hire.Job Locations:
US-NJ-Jersey CityJob ID:
2024-1887# of Openings:
1Category:
Data Science & Medical WritingAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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