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Location
Boston
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-18609
Contact
Yin Yin Pui
Contact email
Email Yin
Contact phone
+65 6692 0751
Posted
大约 5 小时 前

Key Responsibilities:

  • Build, lead, motivate and drive the performance of biometrics US team to achieve agreed objectives, plan and manage resources needs
  • As a member of the Corporate US leadership team and DM & Statistics functional leadership team, contribute to the regional and functional goals, marketing strategy and business development activities
  • Oversee and provide statistical input and guidance related to clinical development from strategic planning to study design, interim analysis and reporting in collaboration with related functions within the organization or external partners and clients
  • Participate in regulatory interactions including document authorship, answering requests and meetings at project level, etc.
  • Collaborate with cross functional peers to facilitate and optimize the clinical development and registration process
  • Actively support business development efforts and contributes to the generation of new business for clinical development solutions through participation in capability presentations, bid defence meetings and other client meetings
  • Maintain and update biometrics related SOPs/WIs and best practice based on regulation, healthy authority guidelines and industry practices; ensure that biometrics activities comply with CDISC, health authority regulation, ICH/GCP guidelines and company SOPs/WIs; develop local specific SOPs as appropriate
  • Lead or participate industry effort in regulatory guidance, consortium and conferences as Corporate Representative
 

Requirements:

  • PhD or MS in Statistics or related discipline.
  • At least 10 years of relevant experience in biotechnology or pharmaceutical industry.
  • In-depth knowledge of statistical analysis methodologies, experimental design.
  • Excellent knowledge of biometrics functions, including biostatistics, SAS programming and data management.
  • Solid understanding of regulatory requirements and clinical trial expertise from phase I to studies.
  • Excellent knowledge of the international pharmaceutical market and operational support to achieve business success.
  • Excellent oral and written communication skills and strong leadership in a team environment.