Biostatistician

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 is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon 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 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 Communication of Results and Inferences
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. 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. 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 communication skills for effective customer consultation Teamwork and leadership skills Technical expertise and application with working knowledge of experimental design and statistical analysis 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)

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