Biostatistics Mgr
Thermo Fisher Scientific
Summary
Join our team as a Staff Scientist in Biostatistics, where you'll contribute to advancing healthcare through data-driven insights and statistical excellence. You'll collaborate with cross-functional teams to design, analyze, and report on clinical trials and product development initiatives. As a statistical expert, you'll help shape the future of healthcare by ensuring the quality and integrity of our research while contributing to therapeutic developments.
Job description
Working in a matrix environment, you'll provide statistical leadership across multiple projects, from study design through analysis and reporting. You'll develop and implement statistical methodologies, create analysis plans, and deliver high-quality statistical reports that drive decision-making. Your expertise will be vital in supporting both new product introductions and ongoing research initiatives, helping ensure our solutions meet the highest standards of scientific rigor.
Responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Able to act as the lead statistician, project lead, or senior reviewer on select projects. Contributes to study proposals and bids, representing the department at bid defenses. Oversees the resourcing of studies, develops and implements strategies to ensure optimal efficiencies around process, programming, and schedule. Provides support, guidance and project leadership to junior and senior team members.
Hiring requirements:
Education requirements: Master's degree and/or Doctorate degree in Biostatistics, Statistics, or Mathematics is required. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Experience requirements: Minimum of 7 years of experience in either the CRO or pharma industries is required. Minimum of 5 years of strong project lead experience is required. Experienced with SAS and R programming is required. Strong client facing and strong project lead, as well as strong hands on stats work is required. Prepares and reviews statistical reports, clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Note: This is not a people management role. This is a project lead role with client facing responsibilities.
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
- Strong knowledge of SAS® and clinical biostatistics
- Strong understanding of the drug development process and FDA regulations
- Capable of managing change and uncertainty to optimize positive outcomes
- Ability to make independent judgments under limited supervision
- Strong interpersonal skills and a collaborative team-oriented mindset
Location: Remote in the United States. Relocation assistance is NOT provided. Must be legally authorized to work in the US without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.
Requirements
- Master's degree and/or Doctorate degree in Biostatistics, Statistics, or Mathematics is required
- Minimum of 7 years of experience in either the CRO or pharma industries is required
- Minimum of 5 years of strong project lead experience is required
- Experienced with SAS and R programming is required
- Strong client facing and strong project lead, as well as strong hands on stats work is required
- Prepares and reviews statistical reports, clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required
- 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
- Strong knowledge of SAS® and clinical biostatistics
- Strong understanding of the drug development process and FDA regulations
- Capable of managing change and uncertainty to optimize positive outcomes
- Ability to make independent judgments under limited supervision
- Strong interpersonal skills and a collaborative team-oriented mindset
- Must be legally authorized to work in the US without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.