Role Description The Associate Biostatistician supports biostatistics activities on one or more studies. Collaborates with study team to determine study design, reviews protocols and statistical analysis plans, supports statistical analysis, and generates reports summarizing findings. Evaluates and contributes to sections of protocols that require statistical input.

• Collaborates with study team to determine study design for research projects.
• Evaluates and contributes to sections of protocols that require statistical input.
• Reviews protocols and case report forms to ensure protocol objectives are met and standards are maintained.
• Generates randomization schedules for randomized clinical research studies and ensures proper implementation and documentation.
• Supports development of statistical analysis plans, other study plans and statistical programming.
• Generates reports to support data and safety monitoring activities.
• Generates quality control and operational reports to support clinical operations.
• Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies.
• Contributes to manuscripts and or scientific presentations.
• Contributes to innovation in Biostatistics that will continuously enhance current statistical knowledge and practices.
• Acquires knowledge of current statistical and medical literature to ensure that sound methodologies are adopted.
• Contributes to review of statistical process development, standardization and improvement across company.
• Provides project updates to appropriate project or department management staff.
• Keeps abreast of and ensures compliance with regulatory practices, example FDA, EMA, and ICH guidance and recommendations.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Master's Degree in Biostatistics, statistics, epidemiology or related field. Required
• Less than 1 year of related experience. Preferred
• Demonstrated proficiency with statistical methods and applications. Preferred
• Strong programming skills in SAS and/or R. Preferred
• Expertise in modern techniques for data manipulation, visualization and statistical methodology. Preferred
• Ability to manage multiple tasks and priorities effectively. Preferred
• Ability to work independently as well as in a team environment. Preferred
• Strong skills in prioritization, problem solving, organization, decision making, and time management. High
• Ability to articulate statistical and technical concepts through written and oral communication. High
• Strong communication, interpersonal and organization skills. High
• Self-motivated, proactive and detail-oriented. High

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment