Biostatistician II

Work Schedule

Environmental Conditions

Job Description

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.

*Must be able to pass a comprehensive background check, which includes a drug screening.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.