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. 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 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. A day in the Life: - 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 thatSOPs 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. 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 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. A day in the Life: - 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 thatSOPs 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.
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