Sr Biostatistician II

Thermo Fisher Scientific • Wilmington, NC

2d • Remote

About The Position

Thermo Fisher Scientific is hiring a senior biostatistician to independently lead statistical work on complex clinical research projects, with minimal oversight. The position delivers project statistician responsibilities, including analysis database creation, statistical analyses, and formatted statistical tables and summaries. The role also provides senior review and mentorship to junior colleagues, and may interact with sponsors and regulatory agencies.

The statistician reviews clinical protocols, sample size calculations, randomization documentation, analysis plans, database specifications, and analyses for key efficacy endpoints. The role collaborates with programmers and data management personnel, prepares reports and manuscripts, and contributes statistical methods sections to integrated clinical and statistical reports and summaries of safety and efficacy. It also monitors project scope and budgets, supports employee and resource planning, represents the department across divisions, and contributes to bids and business development.

The position is remote within the United States. Applicants must be legally authorized to work in the US without sponsorship and must pass a comprehensive background check that includes drug screening. Relocation assistance is not provided.

Requirements

• Master's degree in Biostatistics, Statistics, or Math at a minimum; an equivalent combination of appropriate education, training, and/or directly related experience may be considered.
• Comparable to 4 or more years of relevant experience.
• Project-lead, client-facing experience.
• Experience programming in SAS and R.
• Comprehensive SAS programming skills, proficient in BASE, STAT, MACRO, and GRAPH.
• Ability to direct and promote teamwork in a multidisciplinary team setting.
• Ability to review current processes and identify potential improvements.
• Comprehensive understanding of clinical trials and designs and corresponding data reporting.
• In-depth understanding of interpreting results from statistical analyses of complex data.
• Strong project management skills, including management of multiple projects.
• Demonstrated initiative and motivation.
• Excellent written and verbal communication skills, including English-language proficiency.
• Strong organizational, time-management, and planning skills, including creating and following timelines, long-range planning, adapting to changing priorities, and handling multiple projects.
• Strong interpersonal skills and a positive attitude to work effectively in a team and liaise with other departments.
• Legally authorized to work in the United States without sponsorship.
• Able to pass a comprehensive background check, including drug screening.

Responsibilities

• Lead statistical work independently on challenging and complex projects, including analysis database creation, statistical analyses, and formatted statistical tables and summaries.
• Provide senior review on projects and lead team members across multiple projects.
• Interact with sponsors on project matters and present to sponsors and regulatory agencies as needed.
• Follow departmental SOPs and procedures for statistical analyses and programming, and contribute to changes as needed.
• Review sample size calculations and protocols for completeness, appropriate clinical design, and sound statistical analysis; contribute to protocol sections and review randomization documentation.
• Write and review analysis plans, guide their implementation, define statistical methods and procedures, and review analyses for key efficacy endpoints.
• Review analysis database specifications, oversee database development and completeness, coordinate with programmers and data management on database maintenance and documentation, and supervise table and listing specifications.
• Prepare reports, manuscripts, and other documents; contribute statistical methods sections to integrated clinical and statistical reports and summaries of safety and efficacy.
• Monitor project budgets against scope and communicate potential scope or budget changes to management and sponsors.
• Mentor department members through project guidance, statistical advice, employee development, performance planning, and resource planning.
• Provide input on hiring recommendations, department policies, and resourcing requirements.
• Represent the department to other divisions, assist with bidding and business development, and consult on bids and timelines.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior