Director - Statistics

About the role

The Project Statistician at the Director level provides statistical leadership in multiple dimensions including: Lead the development of clinical plans, innovative study designs, statistical analysis, and interpretation of results at the program level Combine analytical thinking and therapeutic area knowledge to shape internal and external environment to improve the effectiveness of drug development Use strong foundation of statistical experience to enrich decision making, identify efficiencies, and increase the probability of technical success of projects Champion breakthrough approaches to implement innovative statistical methodology and applications Influence team on the critical risks and plan for resolution. Integrate information and make data-driven decisions.

Primary Responsibilities

• Statistical Trial Design and Analysis
  • Provide input on study protocol, design studies and write protocols for the conduct of each study.
  • 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.
  • Perform peer-review of work products from other statistical colleagues.
  • Influence team members regarding appropriate research methods
• Communication of Results and Inferences
  • Collaborate with team members to write reports and communicate results.
  • Aid in, 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.

Qualifications

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

Other Information/Additional Preferences

• Significant experience with clinical trials, medical research, and/or real-world evidence
• 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, etc
• Interpersonal communication skills for effective customer consultation and collaboration
• Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Resource management skills
• Creativity and innovation
• Demonstrated problem solving ability and critical thinking
• Business process expertise associated with critical activities (e.g., regulatory submissions)