We are seeking a skilled statistician to lead our clinical development programs. This is an exciting opportunity for a motivated individual to join our team and contribute to the discovery of life-changing medicines.
Job Overview
* The Clinical Project Statistician will work closely with physicians, clinical research scientists, and medical colleagues to develop protocol designs, clinical plans, and data analysis plans.
This role involves operating in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study. The successful candidate will be responsible for working with research associates and scientists to establish a reporting database and analyzing data for clinical studies.
Key Responsibilities
1. 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.
2. Collaborating with data sciences in the planning and implementation of data quality assurance plans.
3. Maintaining currency with respect to statistical methodology, maintaining proficiency in applying new and varied methods, and being competent in justifying methods selected.
4. Performing peer-review of work products from other statistical colleagues.
5. Influencing team members regarding appropriate research methods.
6. Collaborating with team members to write reports and communicate results.
7. Assisting with or being 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.
8. Responding to regulatory queries and interacting with regulators.
9. Understanding disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and being seen as a strong scientific contributor.
10. Performing work in full compliance with assigned curriculum(s) and being responsible for following applicable corporate, local, and departmental policies, procedures, processes, and training.
11. Introducing and applying innovative methodology and tools to solve critical problems.
12. Merging scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
13. Leading projects independently and working effectively across functions.
14. Applying technical expertise to influence business decisions.
Requirements
* A Master's degree or Ph.D. in Statistics or Biostatistics.
Preferred Qualifications
* Proficiency in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc.
* Interpersonal communication skills for effective customer consultation.
* Teamwork and leadership skills.
* Technical expertise and application with working knowledge of experimental design and statistical analysis.