Biostatistics Senior Manager at Thermo Fisher Scientific

• As a Biostatistics Sr. Manager, you will be responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. You will function as the lead statistician, project lead, or senior reviewer on complex or highly complex studies, whilst providing support and guidance to junior and senior team members. You will serve as a subject matter expert on statistical knowledge and clinical trial related topics. You will contribute to study proposals and bids, representing the department at bid defenses. In this position, you will oversee the resourcing of studies, develop, and implements strategies to ensure optimal efficiencies around process, programming, and schedule.

Essential Functions:

• Serves as (or mentors/coordinates staff in the roles of) lead statistician, project lead, senior reviewer, or project oversight on multiple projects, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.
• Serves as (or mentors others in the role of) the randomization statistician on selected projects.
• Prepares and reviews statistical reports, (or mentors others in the role of) clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports.
• Manages resourcing and delivery strategy of complex books of work - ISS/ISE, submissions etc
• Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives. Conducts training and implementation of new procedures and new industry knowledge.
• Participates in strategic client franchise leadership.
• Provides mentorship and guidance to junior team members; assists people managers with leadership activities, such as interviewing, job description design, etc.

Education and Experience:

• Master degree in statistics, biostatistics, mathematics or related field with 8+ years experience

Knowledge, Skills and Abilities:

• Demonstrated initiative and motivation
• Capable of leading complex projects
• Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff
• Strong verbal and written communication skills
• Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting
• In-depth knowledge of SAS® and clinical biostatistics
• In-depth understanding of the drug development process and FDA regulations
• Capable of managing change and uncertainty to optimize positive outcomes