Description
Biostatistician
Must Have 3-5 years of RELEVANT EXPERIENCE IN BIOTECH/PHARMA.
12 month contract.
Location: Remote.
Objective of Position:
The Biostatistician is responsible for quality and timely statistical support to the assigned tasks under the supervision of the Biostatistics Senior Director.
Essential Duties/ Responsibilities:
• Serves as a study statistician for Phase 1 or 2 studies on the study teams
• Represents Biostatistics in study team meetings
• Develops Statistical Analysis Plans, creates mock-ups for tables, listings, and figures; ensures cross-functional review of those documents is conducted and comments are adjudicated and incorporated as appropriate
• Collaborates with statistical programming to ensure appropriate datasets development and outputs generation
• Reviews tables, listings, and figures produced by statistical programming according to the specifications to ensure accuracy and validity of results
• Provides input on study design, review protocols and author statistical section of a protocol
• Reviews clinical study reports to ensure accuracy and consistency in data presentation, data interpretation statistically sound
• Provides statistical analyses support to publications (e.g. abstracts, presentations and posters, manuscripts), reviews publications to ensure accuracy and consistency in data presentation, and data interpretation statistically sound
• Develop statistical programs as necessary to perform exploratory analyses
Requirements:
• Experience applying statistical methods to drug development and clinical trials
• Understanding of regulatory guidelines in a pharmaceutical research setting
• Excellent communication skills and ability to consistently meet company urgent deliverable s
• Strong implementation skills
Education/Training:
• PhD or MS in Statistics/Biostatistics with prior experience in biotech/pharma industry as a statistician
• Neurology drug development experience is highly preferred
• Proficient in SAS and/or R programming
