Senior Advisor - Statistics

Role Summary

Senior Advisor - Statistics. The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and other research colleagues. The statistician is responsible for establishing a reporting database and analyzing data for clinical studies.

Responsibilities

• 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, proficiency in applying new and varied methods, and justifying methods selected.
• Perform peer-review of work products from other statistical colleagues.
• Influence team members regarding appropriate research methods.

Responsibilities (continued)

• 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, and present at scientific meetings.
• Respond to regulatory queries and interact with regulators.

Qualifications

• Ph.D. in Statistics OR Biostatistics with at least 3 years of experience in Clinical Research and Development.
• Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUGs, etc.

Skills

• Interpersonal communication for effective customer consultation
• Teamwork and leadership skills
• Technical expertise with working knowledge of experimental design and statistical analysis
• Self-management with a focus on timely and accurate completion of deliverables
• Resource management
• Creativity and innovation
• Demonstrated problem solving ability and critical thinking

Education

• Ph.D. in Statistics or Biostatistics (required).