Principal Statistician 2/20/2017

MedImmune, LLC Boulder, CO

Company
MedImmune, LLC
Job Classification
Full Time
Company Ref #
366224
Location
Boulder, CO
Experience
Entry Level (0 - 2 years)
Job Type
Regular
AJE Ref #
577594720

JOB DESCRIPTION

APPLY
div class="overview-left" div class="job-location job-info" b Location: /b Boulder, Colorado, United States br /div b Job reference: /b R-003940 br br b Posted date: /b Feb. 17, 2017 br br ul style="margin-top:40px;" /ul /div br br div class="ats-description" itemprop="description" p If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us. /p p b MedImmune /b is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a b Principal Statistician /b in b Boulder, CO /b , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. /p p We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules. /p p MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. /p p ~bsp /p strong Main Duties and Responsibilities /strong p You will function independently as a principal statistician for multiple projects that provide support primarily to the Quality organization but you may assist other organizations at the Boulder Manufacturing Center. This includes providing consultation about collection and analysis of data obtained for method transfer, product commercialization and regulatory filing, facility qualification activities, process data, and deviations and investigations. You will be responsible for authoring protocols, plans, and reports summarizing statistical analyses and successfully communicating verbally and in writing to non-statistical audiences. In addition, you will be responsible for setting rational and defendable trending limits, acceptance criteria, and process tolerances in support of GMP operations. You will participate in and provide evaluation of data for deviations and investigations, root cause analyses, and regulatory technical writing (BLA/IND/APR). You will work cross-functionally with groups outside Quality as well as with peers throughout the network to establish consistent statistical approaches. You may be required to interact with regulatory agencies verbally and in writing. /p p Primary activities include assessing and analyzing data sets in support of GMP operations. Own and author technical reports detailing statistical analyses. Provide written and verbal communications to non-statistical audiences. Assist in investigations and root cause analysis. Contribute to regulatory filings and annual product review. /p