Company Address: Address 168 Third Avenue, Waltham, MA US
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Sr Biostatistician II
As a Sr Biostatistician II, you will function independently as Lead Statistician on projects and as support/project statistician on others, your responsibilities will include (but are not limited to) the following: Develop statistical analysis plans, including analysis database and tables & listing specifications Provide randomization schemes and appropriate documentation Provide sample size calculations and review protocols for…
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Regulatory Affairs Manager
We are currently seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department – Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. Responsibilities: Lead the preparation of global regulatory submissions and ensure high quality standards that meet local and regional requirements. Act as…
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Principal Programmer Analyst – CDISC SDTM Specialist using SAS
Job Description The Data Transformation and Submission(DTS) group within our Biostatistics & Programming department performs active global CDISC submission development for clients in our Biotech, Biopharma and FSP groups. There is also responsibility for Spotfire exploration, SDTM, DSUR reporting, eCRT (Define.xml) as well as cross functional development initiatives with various internal departments, including CDM, Early…
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Principal Statistical Scientist
Job Description We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning…
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Programming Manager
Responsibilities include: Serve in a project lead role on selected multiple projects. Reviews and ensures adherence to departmental working practice documents and SOPs and contributes to their development. Increases knowledge base and professional skills of staff in areas including programming technology and techniques, clinical trials, and the pharmaceutical industry through on the job training, mentoring,…
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Sr Programmer Analyst – Early Phase Principal Biostatistician – FSP, Customer-Dedicated Principal Statistical Scientist
As a Senior Programmer Analyst within Early Development Services (EDS), you will perform advanced bioinformatics programming activities for the statistical and computational considerations of research projects. Essential Functions: Acts as the lead programmer on selected studies of moderate complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines.…
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Senior Key Account Manager
What will you do? Translating deep customer insights into meaningful partnership opportunities that deliver value to both our customers and Thermo Fisher. You will be driving overall account strategy, improving our breadth and depth of capabilities to build high-impact, innovative, science- and customer-centric solutions Negotiate with knowledge and translate customer insights into partnership opportunities that…
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Senior/Principal Regulatory Affairs Specialist – CTA (Clinical Research Field)
In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice…
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Senior/Principal Programmer Analyst, FSP Senior/Principal Biostatistician, FSP (Client-dedicated) (Senior/Principal) Clinical Team Manager – Neuroscience (Senior/Principal) Clinical Team Manager – Hematology and Oncology
Key Accountabilities/Responsibilities: The Statistical Programmer is responsible for all statistical programming activities. These responsibilities include: Provides relevant input in the development of the statistical analysis plan and mock tables, listings and figures. Performs critical review of derived datasets specifications and derived datasets (ADaM). Develops programs to perform QC of statistical outputs. Defines program specific standards…
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Senior/Regulatory Affairs Specialist – CTA (Clinical Research Field)
The following skills are required to be successful in this position: Experience developing regulatory strategies globally Experience and knowledge of bid defence meetings Experience leading global regulatory projects Client facing experience What the role requires you to have: Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification Previous experience…