Senior Statistician / Principal Statistician - Diabetes & Metabolic Disease

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POST DATE 9/15/2016
END DATE 10/23/2016

AstraZeneca Pharmaceuticals LP Gaithersburg, MD

Company
AstraZeneca Pharmaceuticals LP
Job Classification
Full Time
Company Ref #
360900
AJE Ref #
576179458
Location
Gaithersburg, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Senior/Principal Statistician -- Diabetes and Metabolic Disease br br We are currently seeking experienced Statisticians to join AstraZeneca. br br We have immediate opportunities in our core Therapy Area: Diabetes and Metabolic Disease (DMD). br br Appointment to this position will be at the level consistent with the successful candidates skills and experience. br br As a Statistician in Biometrics & Information Sciences (B&I) - the home of late stage biometrics at AstraZeneca -- you will build on your existing experience and knowledge in DMD statistics to play a crucial role delivering one of the most exciting drug portfolios in the industry. br br Our Therapeutic Area (TA) aligned Statistics groups oversee and deliver the statistical contribution to design, decision-making, interpretations and communication (internally and externally) of the TA portfolio and is engaged in shaping the TA external environment. br br Our Statisticians provide highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies. Statisticians may also lead strategic capability or business area improvements within the Department. Our DMD statisticians also have access to support from our Advanced Analytics Center which houses our statistical innovation, modelling and simulation and design expertise. br br As part of the Statistics community and you will join some of the most respected Statistics experts in the industry, focussed on outstanding programme design and delivery of the quality information we need to meet our drug project objectives that drives product development. br br B&I drives good design to generate the data needed for quality decision making. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions br br Successful candidates will be located at one of AstraZeneca's key strategic science centres in Gaithersburg, MD US or Gothenburg, Sweden br br Core Accountabilities & Responsibilities: br br Senior Statistician br br You will provides statistical expertise to support the design and interpretation of clinical programmes, regulatory submissions and commercialisation and build your career accordingly. br br Analyses internal and external information to inform design decisions and the development of decision criteria br br Provides support to the regulatory submissions including specification of overview documents and response to regulatory questions br br Identifies opportunities for the application of modelling and simulation to improve study design br br Identifies opportunities to improve the methodology and provide practical solutions for problems br br Identifies and applies statistical methodology to improve the process and delivery activities br br Contributes to the development of best practice to improve quality, efficiency and effectiveness br br Principal Statistician br br As a Principal Statistician you will deliver global submissions and have opportunity to be indication lead on crucial elements of our pipeline. br br To lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team. br br Leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations br br Through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions br br Quantifying the benefit, risk, value and uncertainty of the emerging product profile. br br Holding CRO/Partners accountable for the high quality standards of their deliverables; br br Represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications; br br Application of expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. br br Mentor/coach and support the education and training of Statistics staff in the technical arena. br br Report to Director and Biometrics Team Leader