Posted to MedZilla on 4/29/2017

Takeda Pharmaceuticals

US-MA, Principal Statistician / Senior Statistician 1603205-MZ


Please note that the requirements specified in this posting are the basic qualifications required for the Principal Statistician position; however, job title will be dependent on the candidate's level of experience in those requirements.

  • Independently design, analyze and interpre clinical studies at a compound level.
  • Provide strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions.
  • Improve and using standards to maximize global data integratability, interpretability and compound level efficiency
  • Leverage internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables.


  • Independently represent statistics function on global or regional teams in support of clinical studies and projects
  • Promote innovative efficient trial designs
  • Independently conduct trial simulations to assess design options and analysis methodologies
  • Independently develop efficient analysis methodologies and responsible for completion of statistical analysis plan
  • Provide strategic statistical inputs to feasibility assessments, development and submission plans, and defense of regulatory submissions.
  • Plays a key role in the development and review of the study synopsis, protocol, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
  • Oversee definition and implementation of compound-level database (including derived database), analysis and reporting standards. Improve or use existing standards to ensure maximization of global integratibility and interpretability of data and enhance efficiency at compound level. Coordinate with Data Management, Programming, Safety Statistics, Clinical and PV to target high quality databases and specifications at compound level.
  • Plan and direct compound level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
  • Identify compound level vendor requirements. Provide compound level analytical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
  • Identify and interact with external statistical experts for issues related to study design, methodology and results.
  • Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the compound level program. Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
  • Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, and implement innovative



  • PhD in statistics or biostatistics with minimum of 3 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics with minimum 6 years of relevant pharmaceutical industry experience.
  • Profound understanding of clinical study designs, common analysis methods, descriptive and inferential statistics.
  • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
  • Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
  • Strong programming skills with common statistical software including SAS
  • Ability to represent Statistics function in interactions with regulatory agencies.
  • Good vendor management skills
  • Excellent oral and written communications skills.
  • Strong project management skills.
  • Strong collaborative skills and ability to work with a cross-functional team.

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