Sr 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.

Essential Functions:

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

contribute changes as needed. Follows departmental procedures for statistical

analyses and programming work.

• Work independently as a project lead or as lead statistician to deliver on lead

tasks/responsibilities across challenging projects; provides senior review on

projects. Leads team members across multiple complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.

• Reviews sample size calculations and protocols for completeness,

appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Reviews randomization related

documentation.

• Writes / reviews analysis plans and guide others on the team in its

implementation. Defines appropriate methods and procedures for statistical

analysis. Reviews statistical analysis for key efficacy endpoints.

• Reviews specifications for analysis database, oversees its development, and

assures completeness for use in all programming. Oversees collaboration with

programmers and data management personnel as to database maintenance,

updating, and documentation. Supervises creation of table and listing

specifications.

• Prepares reports, manuscripts, and other documents. Contributes statistical

methods section for Integrated Clinical and Statistical Report, Integrated

Summaries of Safety, Integrated Summaries of Efficacy, and other documents.

• Monitors project budget as it relates to project work scope and communicate

proactively with management concerning potential changes in work scope.

Communicates with sponsors concerning project work scope and budgetary

changes after reviewing with management.

• Mentors members of the department by providing project guidance and

statistical advice and by promoting employee development, contributing to

performance planning, and providing resource planning.

• Provides input on hiring recommendations, department policies, and resourcing requirements.

• Acts as representative of the department to other divisions. Assists in bidding

and business development activities. Consults with business development with

respect to bids and timelines

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 4+ years’).

Project lead client facing experience is required.

Experience programming in SAS and R is required.

Knowledge, Skills and Abilities:

• Comprehensive SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH)

• Capable of directing and promoting teamwork in a multi-disciplinary team setting • Capable of reviewing current processes and identify potential process improvements

• Comprehensive understanding of a wide variety of clinical trials/designs and corresponding reporting of data

• In-depth understanding of interpreting the results from statistical analyses of complex data

• Strong project management skills, as shown through management of multiple projects

• Demonstrated initiative and motivation

• Excellent written and verbal communications skills, including proficiency in the English language

• Substantial organizational, time management, and planning skills to create and follow timelines,

conduct long-range planning, adapt to changing priorities and handle multiple projects

…