BioSpace, Inc.
Associate Director - Safety Statistician, Statistical Strategy and Innovation
BioSpace, Inc., Basking Ridge, New Jersey, us, 07920
Associate Director - Safety Statistician, Statistical Strategy and Innovation
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Associate Director - Safety Statistician, Statistical Strategy and Innovation
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BioSpace Associate Director - Safety Statistician, Statistical Strategy and Innovation
3 days ago Be among the first 25 applicants Join to apply for the
Associate Director - Safety Statistician, Statistical Strategy and Innovation
role at
BioSpace Get AI-powered advice on this job and more exclusive features. Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Groups 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology, Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary
Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety signal detection and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant within company for safety analyses.
Responsibilities
Lead for safety signal statistical handling, lead the statistical support in safety signal detection, validation, characterization and reporting in collaboration with safety programming team, CSPV, and epidemiology for several projects with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for ongoing trials. Safety analysis methodology and standardization, develop and support statistical safety analysis methodology and standardization across the clinical development in cross functional teams. Builds partnership with safety programming teams, project statistical teams, and internal cross functional teams and external institutions to maximize available resources. Safety working groups and initiatives, represent statistics to participate (and lead if applicable) in safety signal working groups or cross function initiatives.
Qualifications : Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education
PhD In statistics or Biostatistics required
Experience
Minimum 5 years of relevant experience in the pharmaceutical industry and experiences as a safety statistician required.
Travel
10%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range
$168,000.00 - $252,000.00
Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Management and Manufacturing Industries
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Join to apply for the
Associate Director - Safety Statistician, Statistical Strategy and Innovation
role at
BioSpace Associate Director - Safety Statistician, Statistical Strategy and Innovation
3 days ago Be among the first 25 applicants Join to apply for the
Associate Director - Safety Statistician, Statistical Strategy and Innovation
role at
BioSpace Get AI-powered advice on this job and more exclusive features. Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Groups 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology, Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary
Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety signal detection and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant within company for safety analyses.
Responsibilities
Lead for safety signal statistical handling, lead the statistical support in safety signal detection, validation, characterization and reporting in collaboration with safety programming team, CSPV, and epidemiology for several projects with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for ongoing trials. Safety analysis methodology and standardization, develop and support statistical safety analysis methodology and standardization across the clinical development in cross functional teams. Builds partnership with safety programming teams, project statistical teams, and internal cross functional teams and external institutions to maximize available resources. Safety working groups and initiatives, represent statistics to participate (and lead if applicable) in safety signal working groups or cross function initiatives.
Qualifications : Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education
PhD In statistics or Biostatistics required
Experience
Minimum 5 years of relevant experience in the pharmaceutical industry and experiences as a safety statistician required.
Travel
10%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range
$168,000.00 - $252,000.00
Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Management and Manufacturing Industries
Internet News Referrals increase your chances of interviewing at BioSpace by 2x Get notified about new Safety Director jobs in
Basking Ridge, NJ . Clifton, NJ $120,000.00-$130,000.00 1 week ago Somerset, NJ $115,000.00-$130,000.00 1 month ago Parsippany, NJ $130,000.00-$160,000.00 2 weeks ago Executive Director/Head of Medical Safety Oncology Assets
Basking Ridge, NJ $316,725.00-$527,875.00 6 days ago Bridgewater, NJ $283,000.00-$339,000.00 2 weeks ago Director Quality, Safety and Regulatory (RN)
Somerville, NJ $130,000.00-$180,000.00 1 week ago Senior/Executive Director, Non-Clinical Drug Safety Evaluation
Food Safety & Quality Assurance Director- Woodstock Farms
Raritan, NJ $106,000.00-$246,100.00 4 days ago Newark, NJ $134,000.00-$160,000.00 1 week ago Somerset, NJ $187,989.00-$246,735.00 2 weeks ago Sr. Medical Director - Drug Safety and Pharmacovigilance
Somerset, NJ $285,906.00-$375,253.00 1 week ago Assistant Director Quality & Performance Improvement
Newark, NJ $111,618.00-$167,429.00 2 weeks ago Executive Director/Head of Medical Safety Oncology Assets
Basking Ridge, NJ $316,725.00-$527,875.00 3 weeks ago Food Safety & Quality Assurance Director- Woodstock Farms
New Brunswick, NJ $98,437.50-$127,312.50 4 days ago Morristown, NJ $75,000.00-$85,000.00 2 weeks ago Associate Director, External Manufacturing Operations - Medical Devices
Vice President of Real Estate, Facilities, & Infrastructure
Florham Park, NJ $152,435.00-$201,979.50 2 weeks ago Perth Amboy, NJ $80,000.00-$90,000.00 2 months ago Director Supply Planning & Inventory Mgmt
Elizabeth, NJ $138,750.00-$231,250.00 2 months ago Morristown, NJ $97,000.00-$125,000.00 1 day ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr