Associate Director, Statistics

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.What you bring to Abbott can bring hope to the world. At Abbott, we're in the business of turning science into healing. From nutrition and diagnostics through medical care and pharmaceutical therapy, we make long-lasting contributions to the world's health. With over 65,000 employees worldwide, and $25 billion in sales in more than 130 countries, we're not just poised to enhance the health of the world --- we're positioned to make it happen. Abbott's corporate headquarters is in the north suburbs of Chicago, with 11,000 associates employed at Abbott Park, Illinois. Abbott is considered a premier employer, offering excellent benefits, competitive salaries and exciting career opportunities. Abbott is ranked among the top companies in the world for financial strength and workplace excellence by leading national publications including: Fortune, Forbes, Science, and BusinessWeek, to name a few.Abbott is seeking an experienced Associate Director, Statistics to join the team in north Chicago. Relocation assistance is available. Key Responsibilities:PROTOCOL DEVELOPMENT, RANDOMIZATION SCHEDULE, AND DATABASE ACTIVITIES·Works with project team to decide on appropriate study design, statistical methodology, and alignment with development program·Responsible for ensuring that a comprehensive protocol review is provided by the statistics organization·Responsible for specifications and adherence to procedures for randomization schedules, and for sample size and power calculations·Responsible for assuring that data for statistical analyses are accurate STATISTICAL ANALYSES·Responsible for implementation of protocol methodology and statistical analysis plans·Responsible for the accuracy and timeliness of statistical input into reports or decisions and for ensuring that documentation processes are followed ·Demonstrates extensive understanding of statistical concepts and methodology's and when changes to planned analyses are needed-Demonstrates awareness of innovative methods and can partner with others to assess their appropriateness-Recognizes and corrects/communicates flaws and limitations in scientific reasoning and statistical interpretation. SCIENTIFIC REPORTS AND PUBLICATIONS·Responsible for ensuring the accuracy of statistical tables and accuracy of report text, including interpretation of results.-Partners effectively with clinical and commercial colleagues on development of publication plans and content strategyCONSULTATION -Collaborates with multiple stakeholders to develop scientifically appropriate development strategies ·Collaborates with peers to develop efficient designs, quality protocols and reports per agreed timelines·Provides accurate and timely answers to questions from clients, and provides scientific insight when answering nonstandard questions·Effectively presents statistical concepts and arguments to management, regulatory agencies and scientists-Provides proposals for program strategy and works with others to ensure that the program provides statistical and scientific rigor, and quality to meet objectives and global regulatory needs.TRAINING, SUPERVISION, MENTORING-Effectively mentors other development stakeholders with regard to statistical methodology and departmental operations. -Provides appropriate background, motivation, and training to staff. -Manages 3-8 statisticians by appropriately delegating assignments, reviewing activities, and defining deliverables so that projects are delivered on time with suitable quality. -Arranges appropriate training opportunities for staff to facilitate their timely career development. -Seen as a project leader on key initiatives -Seen as a valuable resource within the statistical organization on one or more statistical topics or therapeutic areas and can provide formal training to others when neededPROJECT COORDINATION AND REGULATORY ACTIVITIES·Effectively interacts with project leaders, Regulatory Affairs, FDA and other regulatory authorities -Can function as a single point of contact within the statistical organization for a project or therapeutic area·Responsible for the accuracy and appropriateness of statistical input (protocol design, statistical methodology, interpretation of results) for regulatory submissions and development decisions-Demonstrates an accurate understanding of current regulatory requirements and emerging trends that could affect the design, conduct, analysis, or interpretation of clinical programs.QualificationsA minimum of 8+ yrs experience in pharmaceutical development and applied statistics/statistical consulting with a PhD Statistics or related degree; or 12+ years relevant experience with MS Statistics or related degree. Experience in preparing for NDA, BLA, and/or CTD submissions. High degree of technical competence and communicative ability, both oral and written. Highly competent in experimental design, descriptive and inferential statistics, and computer systems, especially in medical applications. Pharmaceutical or related industry experience with clinical trials, including interaction with regulatory agencies, especially, FDA. Knowledge of the guidelines of worldwide regulatory agencies; the ability to advise the Global Project Teams and other scientists in the methodology and design of clinical studies. M.S./Ph.D. degree in statistics, biostatistics, biometrics, or related field.Abbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.