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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

This role offers hybrid or remote working flexibility.

Discover Impactful Work:

Serves as a project lead or lead statistician to deliver on tasks/responsibilities for multiple complex protocols, projects, or NDA projects, including coordinating with other divisions and interacting with the client and regulatory agencies. Mentors others in the application of more complex statistical methodologies. Performs project management functions relating to the administrative and scientific activities of team members across multiple complex projects. Provides senior-level oversight of statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Represents the department to clients on simple to complex study design matters, directly contributing to simple to complex study proposals and bids and representing the department at bid defenses. Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies.

A day in the Life:

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. Works 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.

Keys to Success:

Education & Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’). Master's degree in statistics, biostatistics, mathematics or related field

Knowledge, Skills, 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 Strong interpersonal skills and positive attitude to work effectively in a team environment and act as a liaison with other department

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!