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Study Lead Statistician
Job Description
*Depending on experience
Position Summary:
The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.
Responsibilities:
• Perform all duties and responsibilities associated with the Study Lead Statistician role
• Attend Clinical Study Team meetings and provide all required statistical input related to strategy and operations of the clinical study.
• Plan and execute statistical contributions to Study Outlines, protocols,, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, Submission Data File specifications, other key-study related documentation, protocol deviations, Data Quality Review, and Clinical Study Reports (CSRs).
• Be familiar with statistical policy and strategy.
• Stay abreast of latest developments in the field of statistics in drug development.
Qualifications and Skills Required:
• PhD in statistics or related field and at least 6 years of industry experience or MS in statistics or related field and at least 10 years of industry experience
• Comprehensive knowledge of clinical trials methodology, regulatory requirements, HEOR, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically
• Proficient in Microsoft Office
• Professional, proactive demeanor
• Excellent written and verbal communication skills
• Experience with people management and development of staff
• Excellent interpersonal and project management skills
• Able to collaborate effectively with internal and external study management teams to meet project timelines
• Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results
*CO/NYC candidates might not be considered
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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