Senior Biostatistician II - Atlanta, United States - Mindlance

Description

Job Title: Senior Biostatistician II

Job Location: Remote

MUST HAVES/Top Skills:

• Lead level experience to respond to FDA inquiries
• Experience with ADaM Datasets and generate and review TLF shells
• Submission experience
• Preferred: experience in submission responses with fast turnaround

SUMMARY OF ROLE:

• Serves as a project lead or lead statistician overseeing tasks for multiple complex protocols, projects, or NDA projects
• Mentors others in applying advanced statistical methodologies
• Provides oversight on statistical aspects in clinical trial design and analysis
• Represents the department in client interactions and study proposals
• Organizes teams to enhance process and programming efficiencies

ESSENTIAL FUNCTIONS AND OTHER JOB INFORMATION:

Essential Functions:

• Ensures compliance with departmental SOPs and suggests changes as necessary
• Works independently as a project lead on challenging projects
• Reviews sample size calculations and protocols
• Writes and reviews analysis plans
• Oversees development of analysis database and collaborates with programmers and data management personnel
• Prepares reports and contributes to statistical sections in various documents
• Monitors project budget and communicates changes to management
• Mentors department members and provides input on hiring and policies
• Acts as department representative in bidding and business development

Job Knowledge: Experienced professional with a strong understanding of the field

Supervision: Receives little instruction on day-to-day work

Business Relationships: Prime contact representing the department on projects

EDUCATION AND EXPERIENCE:

• 4+ years of previous relevant experience
• Master's degree in statistics, biostatistics, mathematics, or related field
• Equivalent combination of education and experience considered