AstraZeneca Pharmaceuticals LP
TITLE: Principal Statistician; multiple position(s) available (Durham, NC, Mon-Fri, 40 hrs/week);
DUTIES: Provide statistical expertise for complex design and interpretation of clinical studies, regulatory submissions, and support of product commercialization. Analyze internal and external information to inform design decisions and the development of decision criteria. Lead the development of Statistical Analysis plans for clinical studies and/or project deliveries. Provide support to clinical study analysis, regulatory submissions including specification of overview documents and response to regulatory questions. Identify opportunities for the application of modelling and simulation to improve study design. Identify and apply statistical methodology to improve the process and delivery activities. Perform ad hoc and exploratory data analyses. Contribute to the development of best practice to improve quality, efficiency and effectiveness.
REQUIREMENTS: Must have a PhD or foreign equivalent in Statistics or a related mathematical field plus five (5) years of experience in the position offered, as a Research Statistician or a related position. Must have five (5) years of experience with: Researching and developing statistical methodology related to the design of late phase clinical trials; Statistical programming skills including SAS and R; Conducting clinical trials in accordance with ICH and GCP regulatory standards; Drug development, study design, data analysis and interpretation; Leading and directing project work for late phase clinical trials and Using statistics to analyze design, complex problems, problem solving and quality focus to support for late phase clinical study analyses. In the alternative the employer will accept a Master’s degree in a stated field of study plus eight (8) years of experience. 20% travel to various and unanticipated sites nationally and internationally. All employment related travel expenses paid by employer pursuant to internal policy.
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.