At a leading pharmaceutical organization, we strive to combine compassion with discovery to make life better for people around the world. Our team members work diligently to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
Job Title: Clinical Project Statistician
The ideal candidate will be a leader in our clinical development programs, understanding patient and business needs and developing protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and medical colleagues.
* 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.
* Perform peer-review of work products from other statistical colleagues.
* Influence team members regarding appropriate research methods
* 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.
* 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.
* 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.
* 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.
Minimum Qualification Requirements:
* A Master's or Doctoral degree in Statistics or Biostatistics.
Preferred Qualifications:
* Proficiency in statistical programming languages/software such as SAS, R, Spotfire, WinBUGS, etc.
* Strong interpersonal communication skills for effective customer consultation.
* Teamwork and leadership skills.
* Technical expertise and application with working knowledge of experimental design and statistical analysis.
What We Offer:
We offer a dynamic work environment, opportunities for professional growth and development, and a competitive compensation package.