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Job Description - Clinical Project Statistician
Purpose
As a Clinical Statistician, you will be a leader in our clinical development programs. You will understand the patient and business needs and then develop or assist in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and/or medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analysing data for clinical studies.
Primary Responsibilities:
This job description provides a general overview of the job requirements at the time it was prepared. Job requirements may change over time and include additional responsibilities. Consult with your supervisor regarding your actual responsibilities. The tasks listed outline the scope of the position and may vary based on current business needs.
Statistical Trial Design and Analysis
* Operate in collaboration with study personnel to provide input on study protocol, design studies, and write protocols for each study.
* Assist in or be accountable for selecting statistical methods for data analysis, authoring the relevant sections of the protocol and analysis plan, and conducting analyses once a reporting database is created.
* Collaborate with data sciences in planning and implementing data quality assurance plans.
* Maintain currency with statistical methodologies, apply new methods, and justify methods selected.
* Perform peer reviews of work products from other statisticians.
* Influence team members regarding research methods.
Communication of Results and Inferences
* Collaborate to write reports and communicate results.
* Assist or be responsible for communicating study results via regulatory submissions, manuscripts, oral presentations, and one-on-one with key customers.
* Respond to regulatory queries and interact with regulators.
Therapeutic Area Knowledge
* Understand disease states, competitive landscapes, and regulatory environments to enhance collaboration and scientific contribution.
Regulatory Compliance
* Perform work in full compliance with applicable policies, procedures, and training.
Statistical Leadership and Teamwork
* Apply innovative methodologies to solve problems.
* Merge scientific thinking with business knowledge to evaluate issues and implement solutions.
* Lead projects independently and work across functions, influencing business decisions.
Minimum Qualification Requirements:
* M.S., Ph.D., in Statistics or Biostatistics
Other Information/Additional Preferences
* Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc.
* Interpersonal and communication skills for effective consultation.
* Teamwork and leadership skills.
* Knowledge of experimental design and statistical analysis.
* Self-management skills for timely and accurate deliverables.
* Resource management skills.
* Creativity, innovation, problem-solving, and critical thinking abilities.
* Experience with regulatory submissions and business processes.
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