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 Position Overview Lead full scope of Biostatistics contributions to support the Commercial development (ComDev) functions. Provide scientifically rigorous statistical input for supporting ComDev launch strategy. Partner with clinical stat TA lead and colleagues from ComDev functions. Influence and contribute to ComDev strategy to support product launch and life-cycle management, collaborate with cross-functional team for governance reviews. Ensure full integration of statistical strategy and quantitative evaluation and interpretation of adhoc analysis results. Coordinate priorities and monitor operations within the responsible areas. Ensure timeliness and quality of deliverables. Develop analysis plan for ad-hoc analysis requests of clinical trial data from Medical Affairs, Health Economic and Outcome Research. Manage cross-function analysis plan review to ensure proper statistical methods are utilized and will deliver the desired outputs. Leads development of TFL shells, including authoring and managing team review. Collaborates closely with Statistical Programmers in the development of ad-hoc analysis specifications, programming, QC and production, as well as other tasks to support analysis requests from CSL commercial development functions. Makes statistical contributions to external publications, including authoring of statistical methods and data interpretation. Education, Professional Skills & Experience Education: M.S. or PhD in Statistics or related field. Experience: PhD with 8 years of experience or M.S. with 13 years of experience in drug development Advanced knowledge and training in applications of statistical methodologies Ability to collaboratively work in matrix environment and provide statistical expertise in matrix environment Willing to proactively explore the clinical trial data independently with high-level supervision and effectively communicate with CSL teams Hands-on experience with data mining analysis Project management skills to enable meeting deliverable requirements in a timely manner and with high quality. Be able to summarize the ad-hoc analysis results in an effective way Strong interpersonal and communication skills (verbal and written in English). Good working knowledge of SAS and/or R Efficiency with Microsoft Office (Outlook, Word, Excel, and PowerPoint) and SharePoint 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! 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. Apply today! http://jobs.thermofisher.com 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.