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. 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.
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We are currently looking for a Biostatistician II to join our team, on a client dedicated basis. As a Biostatistician within this team, you can expect to be responsible for the following;
- 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
Qualifications;
• At least 3 years industry experience in a Biopharma or Biotech
• Education: A minimum of a Master's Degree in Statistics
• Lead experience: Experience leading a project team - Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Coordinates with programmers and data management personnel.
• 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, 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.
• Required Systems Experience: SAS required. R experience preferable. Experience working on client systems preferable and/or Biopharma or Biotech background.
Work Environment
Thermo Fisher Scientific values the health and wellbeing 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.