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Senior Manager – Biostatistics

Senior Manager – Biostatistics

CompanyTakeda
LocationBoston, MA, USA
Salary$137000 – $215270
TypeFull-Time
Degrees
Experience LevelSenior

Requirements

  • Knowledge of drug development, clinical study design, trial simulations, analysis methodology and data interpretation.
  • Strong statistical programming skills (SAS and/or R).
  • Knowledge of FDA and ICH regulations and industry standards applicable to study design, data analysis of clinical trials and regulatory submissions.
  • Excellent oral and written communications skills.
  • Strong project management and time management skills.
  • Strong collaborative skills and ability to effectively work with a cross-functional team.

Responsibilities

  • Design clinical trials, provide strategic inputs and innovative solutions, and support the team to make data-driven quantitative decisions.
  • Conduct advanced statistical analysis and ensure robust and accurate data analysis through extensive knowledge in biostatistics.
  • Support the adoption of novel designs and innovative statistical methods.
  • Facilitate execution and delivery collaboration with cross-functional teams to achieve project objectives.
  • Lead and be accountable for study level delivery strategies being implemented with effective risk identification and mitigation.

Preferred Qualifications

  • Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases. (Experience in Oncology preferred.)
  • Innovative thinker, driving the adoption of novel design, innovative statistical methods and complex modeling.
  • Strong inter-personal skills.