Biostatistics Mgr

Thermo Fisher Scientific•Wilmington, NC

8d•Remote

About The Position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. As part of our clinical research portfolio, our prospective real-world studies evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on – now and in the future. What will you do in this role? 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. 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. Note: This is not a people management role. This is a project lead role with client facing responsibilities.

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.
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.
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.

Nice To Haves

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

Responsibilities

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.