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Position: Senior Statistician
Institution: AstraZeneca
Location: Gaithersburg, Maryland, United States
Duties: Lead the statistical analysis plans for complex studies. Investigate and apply novel statistical approaches to relevant statistical issues and/or regulatory guidance and value demonstration to support development programs and bring new medicines to patients. Investigate and improve statistical approaches and establish standards and best practice. Develop and implement new methodology interacting with external scientists in order to ensure the most up-to-date techniques are being used within development programs. Identify new areas for improvement, develop collaborative relationships with the external scientific and academic community, and maintain academic links
Requirements: Must have a Master’s degree or foreign equivalent in Statistics, Mathematics or a related field plus two (2) years of experience in the position offered, as a Biostatistician, or a related position. Must have two (2) years of experience in each of the following: Statistical programming including SAS and R to produce analyses to support pharmaceutical development of regulatory and payer submissions and approvals; Implementation of technical and regulatory requirements within the pharmaceutical industry to support design and interpretation of development programs
   
Text: Skip to main content AstraZeneca Careers Home About AstraZeneca Life at AstraZeneca Early Talent Our Locations Inclusion & Diversity Application Hints & Tips FAQs Saved Jobs English русский Deutsch Français 中文 Svenska Senior Statistician Location Gaithersburg, Maryland, United States Job ID R-123592 Date posted 10.11.2021 AstraZeneca Pharmaceuticals LP TITLE: Senior Statistician LOCATION: Gaithersburg, MD HOURS: 40 hrs/week; Mon - Fri 9am-5pm DUTIES: Lead the statistical analysis plans for complex studies. Investigate and apply novel statistical approaches to relevant statistical issues and/or regulatory guidance and value demonstration to support development programs and bring new medicines to patients. Investigate and improve statistical approaches and establish standards and best practice. Develop and implement new methodology interacting with external scientists in order to ensure the most up-to-date techniques are being used within development programs. Identify new areas for improvement, develop collaborative relationships with the external scientific and academic community, and maintain academic links. Contribute to the development of a process improvement and capability area within the department to ensure work is compliant with regulatory requirements. Contribute to peer review by communicating research and results internally and externally through participation at conferences and journal publications. REQUIREMENTS: Must have a Master’s degree or foreign equivalent in Statistics, Mathematics or a related field plus two (2) years of experience in the position offered, as a Biostatistician, or a related position. Must have two (2) years of experience in each of the following: Statistical programming including SAS and R to produce analyses to support pharmaceutical development of regulatory and payer submissions and approvals; Implementation of technical and regulatory requirements within the pharmaceutical industry to support design and interpretation of development programs; Design, analysis and reporting of complex non-clinical and clinical studies; Identifying and applying statistical methods and applications including generalized linear models, Bayesian models, and tipping point analysis in study design, analysis and interpretation; Adaptive sequential designs with sample size re-estimation to achieve sufficient power; and Modeling and simulation to inform design decisions and the development of decision criteria. Employer will accept pre- or post-Master's degree experience. Any suitable combination of education, training or experience is acceptable. Click apply. No calls please. EOE. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. Describe a day in the life of your role? Video length 1:29 So, describe a day in the life of my role. So my role is a Study Physician, I work in oncology. So my role is to be the medical voice, if you will, of the company in a clinical trial or multiple clinical trials. Not every day looks the same, every day is quite different. There are some patterns that I would start with, so for example, I will check out my communications first thing in the morning, and I will triage them like I would as a doctor of any type. I try to deal with the urgent queries first in terms of like safety, toxicity, trial eligibility and trying to deal with all those issues and make sure that things are well in place with your local colleagues, with associates, with investigators so that you're all aligned and making sure that the patients are looked after first and foremost, anyone who's actually on the clinical trial. Then, there are a whole series of recurring meetings, with regards to different functions of the job. So, they're what we call cross-functional team meetings, which will be very similar to what a multi discipline team meetings in a clinical setting but where I'm meeting with other key members such as operations with statistics, with translational medicine and so on and so fourth to make sure that the trials are being conducted accordingly. Then of course, there are other activities I'm involved in including safety management, data management, developments of new clinical trials and review of results and, yeah, it's very varied. Logo Gabriel Study Physician Explore the local area Take a look at the map to see what’s nearby. Medical Evidence Generation Lead Gaithersburg Statistical Science Director, Late Oncology Gaithersburg, Wilmington, Waltham, South San Francisco Senior Statistical Programmer II, Late Oncology Gaithersburg, Wilmington, Waltham, South San Francisco Global Development Scientist Director (Breast Cancer) Gaithersburg, Warsaw We’ll keep you up to date Sign up to be the first to receive job updates. Email Address Interested In Search for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert. Category Location Confirm Email Alt About Us We are AstraZeneca, one of the world’s most forward-thinking and connected BioPharmaceutical companies. Explore our world. alt Life at AstraZeneca At AstraZeneca, our purpose is to help patients all over the world by delivering life-changing medicines as one collaborative team. alt Inclusion & Diversity The success of AstraZeneca is founded on innovation, creativity and diversity. Discover what this means for you. Glassdoor logo Rated four stars on Glassdoor Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity. AstraZeneca Logo Site map Cookie policy Privacy policy Legal notice Astrazeneca.com Loading...
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