Biotech/Pharmaceutical

Principal Research Scientist, Statistics – Remote

Permanent

Penfield Search Partners

Contact: Sue Devine – 203.307.0056 – sdevine@penfieldsearch.com 

The Project Statistician at the Principal Research Scientist level provides statistical leadership in multiple dimensions including:

  • Provides technical leadership and expertise in initiating and executing multi-disciplinary or cross functional projects that impact the company Research Laboratory and the Statistical Sciences organization;
  • Leads the assessment and introduction of new statistical technology and methodology to apply to broader practice;
  • Leads the development of clinical plans, innovative protocol designs, and statistical analysis plans in collaboration with physicians and/or medical colleagues;
  • Provides consulting and statistical direction on priority clinical projects.

Key Responsibilities:

  • The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs.
  • Statistical Trial Design and Analysis
  • Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
  • Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created.
  • Collaborate with data sciences in the planning and implementation of data quality assurance plans.
  • Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
  • Influence team members regarding appropriate research methods
  • Perform peer-review of work products from other statistical colleagues.
  • Communication of Results and Inferences
  • Collaborate with team members to write reports and communicate results.
  • Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
  • Respond to regulatory queries and interact with regulators.

Therapeutic Area Knowledge

  • Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.

Regulatory Compliance

  • Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.

Statistical leadership and Teamwork

  • Introduce and apply innovative methodology and tools to solve critical problems
  • Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
  • Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.

Basic Qualifications:

  • Ph.D. in Statistics OR Biostatistics
  • At least 7 years of proven experience in clinical research and development

Additional Skills/Preferences:

  • Significant experience with clinical trials, medical research, and/or real-world evidence
  • Technical expertise and application with working knowledge of experimental design and statistical analysis
  • An established track record of developing and maintaining an area of statistical or collaborative research
  • Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc.
  • Demonstrated problem solving ability and critical thinking
  • Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions.
  • Interpersonal communication skills for effective customer consultation and collaboration
  • Creativity and innovation
  • Business process expertise associated with critical activities (e.g. regulatory submissions)

Tagged as: Principal Research Scientist, Statistics - Remote