Job Description

Fully Remote - EST preferred but can be in any time zone


*** Max BR to *** - Including MSP fee


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 at ***.
• 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

Job Tags

Remote job,

Similar Jobs