Sr Biostatistician

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.  

In Biostatistics and Programming, we are passionate about data and technical agility to drive enhanced value for our customers and patients. Determined to improve patient health, we provide statistics, programming and clinical pharmacology expertise through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we deliver clinical trial planning and development programs, results of a study and lead the regulatory submissions.  

Discover Impactful Work: 

Functions independently as a project lead or lead statistician to deliver theproject tasks/responsibilities. Performs project management functions relating to the administrative and scientific activities of specific project work and team members. Oversees statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies. 

A day in the Life: 

• Ensures compliance with the activities outlined in the department's Working Practice Documents and contributes 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 large and complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed. 

• Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Provides randomization schemes and appropriate documentation. 

• Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis. 

• Provides specifications for analysis database, oversee its development, and assures completeness for use in all programming. Coordinates with programmers and data management personnel as to database maintenance, updating, and documentation. Performs statistical analysis for key efficacy endpoints. 

• 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, completing performance planning, and providing resource planning. 

• Provides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department or policies, assists with newsletter, helps in department libraries, or trains new hires). 

• Acts as the representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines. 

Education 

• Master's degree in statistics, biostatistics, mathematics or related field.  

Experience 

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) 

Knowledge, Skills, Abilities 

• Strong SAS® programming skills 

• (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures 

• Capable of directing and promoting teamwork in a multi-disciplinary team setting 

• Strong understanding of statisticalprinciples and strong statistical skills 

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

• Demonstrated initiative and motivation 

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

• Strong 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 departments 

Work Environment 

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: 

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

• Able to work upright and stationary for typical working hours. 

• Ability to use and learn standard office equipment and technology with proficiency. 

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 

• May require travel. (Recruiter will provide more details.) 

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 with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.  

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. 

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.