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Daiichi Sankyo, Inc. · 3 days ago
Associate Director, Evidence Generation Biostatistics
United States
Full-time
Remote
Director
5+ years exp
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Responsibilities
Study Responsibility - Responsible, with limited supervision, for study activities assigned, e.g. for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Review CRF; Write SAP; Manage statistical analysis outputs with programming team; Ensure the interpretation of statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses required, including analyses of patient-reported outcomes (PROs) and Health Economic endpoints; Coordinate the statistical programmers involved in the development and execution of analyses; Provide guidance of the proper interpretation of statistical analysis results; Review or co-author the value dossier and scientific communications. Ensure timely, to budget and accurate completion of Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as prepare potential audits linked to assigned studies.
Vendor Oversight Under limited supervision, responsible for providing direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. Responsible, under supervision, for CRO selection from RFI (Request for Information) to contract agreement including, review and negotiation of base-line budget and timelines. Oversees budget management activities across the study duration.
Operational Excellence and Innovation May lead and/or participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions. Maintains current knowledge of industry best practice in statistical methodology. May act as Subject Matter Expert for Statistics, by providing guidance and support to EG team members as well as representing EG department in cross-functional teams. Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards. Demonstrates leadership within Biostatistics by partnering with internal and external stakeholders to optimize Statistics technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).
Qualification
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Required
Master's Degree in statistics, mathematics or related fields required
At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting preferred
Preferred
PhD in statistics, mathematics or related fields preferred
4 or More Years Experience in oncology Therapeutic Area and/or in late phase projects is preferred
Ability to travel up to 20% domestically and internationally
Company
Daiichi Sankyo, Inc.
At Daiichi Sankyo, we create essential medicine for longer, better lives.
10,001+ employees
H1B Sponsorship
Daiichi Sankyo, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (14)
2022 (13)
2021 (7)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
Endpoints News
2024-05-29
2024-05-28
Google Patent
2024-04-13
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