Biotech/Pharmaceutical

Sr. Principal Statistician

Permanent

Penfield Search Partners

Contact: Barbara Day – 201.784.9028 – bday@penfieldsearch.com

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future with our Client.  Join us as a Principal/Sr. Principal Statistician in their Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Principal/Sr. Principal Statistician, you will be empowered to provide statistical leadership and work in complex programs, and a typical day will include:

Objective: The purpose of this position is to provide indication level / development phase statistical expertise and leadership by:

  • Providing statistical leadership in the design, analysis, and interpretation of clinical studies at an indication level with complex programs
  • Promoting innovative design and efficient analysis methodology.
  • Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses, and regulatory submissions.
  • Improving and using standards to maximize global data integrability, interpretability and indication level efficiency
  • Leveraging internal and external resources to achieve quality, timely and cost-effective indication level and submission deliverables.
  • As appropriate independently representing Statistics function in interactions with regulatory authorities on study design and submissions.

Accountabilities:

  • Actively participate in and contribute to decision making related to clinical development strategies, regulatory strategies, and commercial strategies.
  • Promote innovative design and analysis methodology
  • Provide statistical leadership in design, analysis, and interpretation of clinical studies at an indication level within large complex programs.
  • As appropriate independently represent statistics function on global teams in support of clinical studies and compound level programs.
  • Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions.
  • Negotiate timelines (statistical) at indication level.
  • Plays a role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
  • Oversee definition and implementation of indication-level database (including derived database), analysis and reporting standards.
  • Improve or use existing standards to ensure maximization of global integrability and interpretability of data and enhance efficiency at indication level.
  • Coordinate with Data Management, Programming, Clinical and PV to target high quality databases and specifications at indication level.
  • Plan and direct indication level analysis and reporting activities (e.g., tables, listings, graphs) including work of other statisticians and programmers.
  • Identify compound level vendor requirements and participate in the evaluation/selection of vendors.
  • Provide indication 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 program.
  • Propose and implement solutions.
  • Escalate issues to management as appropriate in a timely manner.
  • Lead the implementation of department standards and process improvements.
  • Lead evaluation and implementation of alternative analysis methodology and data presentation techniques.
  • Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods and implement innovative approaches.

Education, Experience and Skills:

  • Generally requires PhD in statistics or biostatistics with at least 4 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics with at least 6 years of relevant pharmaceutical industry experience.
  • PhD required for Oncology roles.
  • Experience with global regulatory submissions.
  • Advanced knowledge 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.
  • Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Excellent oral and written communications skills.
  • Strong project management skills.
  • Strong collaborative skills and ability to work with a cross-functional team.

Tagged as: Sr. Principal Statistician