Biostatistician II

Biostatistician II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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?

Functions independently as a lead statistician with minimal oversight to deliver the project statistician tasks/responsibilities, including analysis database creation, statistical analyses, and creation of formatted statistical analysis tables and summaries. Provides mentorship to junior team members.

• Ensures compliance with the activities outlined in the department's SOPs.

Follows departmental procedures for statistical analyses and programming work.

• Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget.

Ensures that SOPs are being followed and that appropriate project documentation is ongoing.

• Interacts with the sponsor on all aspects of the project.

• Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis.

• Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis.

• Provides randomization schemes and appropriate documentation.

• Develops statistical analysis plan, including analysis database and table and listing specifications, and guide others on the team in its implementation.

• Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating.

• Reviews reports and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report.

• Monitors project budget as it relates to project work scope and communicates proactively with management concerning potential changes in work scope.

• Provides general infrastructure support to the department. Examples could include presentation/ teaching at department, contributing to other general department documents or policies, assisting with newsletters, helping in department libraries, or training of new hires.

Hiring Qualifications:

Education requirements:

Masters in Biostatistics, Statistics or Math at a minimum 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:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

Project lead client facing experience is required.

Experience programming in SAS and R is required.

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.

Accessibility/Disability Access

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