Director Biostatistics

Allergan

Marlow, UK

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Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and driveresults for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Join one of the world’s fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Summary

The position will have three function responsibilities. One (approximately 60%) is for the activities of Biostatistics for multiple therapeutic areas to ensure that Allergan Health Economics and Outcomes Research (HEOR) programs/projects are correctly designed, properly analysed and clearly presented to support drug reimbursement effort, domestic and international regulatory submission and health outcome instrument development for the maintenance and growth of company existing products. The 2nd (approximately 20%) is for the activities of Biostatistics for multiple therapeutic areas to ensure that Allergan Medical Organization clinical trials are correctly designed, properly analysed and clearly presented to support post marketing product strategy and publication development. The 3rd (approximately 20%) is to cover for any later phase (II/III) clinical study for global regulatory submission development part of the tasks in an as needed base.

Key Duties/Responsibilities

Approve HEOR study/project and Medical Organization clinical and publication study/projects documents (Analysis Plan, statistical summary report, study memo, publication

Selects and hires qualified and cost-effective CROs to obtain optimal mixture of internal and external resources. Monitors the performance of CROs to ensure high quality products and services.

Oversees all the bio-statistical activities in the assigned therapeutic areas; Ensures completion of all biostatistics activities with high quality per project timelines and accordance with all defined SOPs, WIs, and supporting documents; Serves as the key contact with Medical Affair clinical scientists, study managers, and publication managers; Mentors/oversees junior level biostatistician

Directs and manages statistical activates within the CMONC/HEOR and/or Medical clinical and publication biostatistics group; Interacts and coordinates with internal and external parties in clinical development, HTA submission, medical affairs, and CROs; Oversees bio-statistical supports and resources cross all therapeutic areas; Establishes standard operational procedures and working instructions, and monitors compliance; Monitors group project status document update progress and hosts project update overview meetings to ensure the milestone tracking is up to the date; Hires, mentors and manages employees; Provides supervision for direct reports and conducts annual performance evaluations

Minimum Requirements

A person with education or education/experience combination equivalent to a post graduate degree in statistics or statistics related field. Ten (10) years of pharmaceutical experience with Ph.D. or Ph.D. equivalent or twelve (12) years of pharmaceutical experience with MS or MS equivalent

Four (4) years of supervisory and management experiences in the pharmaceutical research environment.

Essential Skills And Abilities

  • Great working knowledge of drug reimbursement regulation, HTA submission, Cost-Effectiveness Analysis (CEA), PRO (Patient Repot Outcomes) evaluation methodology and skills (test-retest, reliability, MID, know-group convergence, and Item Response Theory)
  • Great working knowledge of non-sequential and sequential clinical trial methodologies, advanced statistical theory and methods including specific knowledge of experimental design, analysis of variance and linear models, survival analysis, categorical analysis, multivariate analysis, robust estimation, and nonparametric techniques.
  • Great working Knowledge of at least one statistical software package (such as SAS, R, S-Plus, BMDP, PASS, nQuery).
  • Excellent analytical, problem solving, and computer skills.
  • Flexible, well organized, excellent verbal and written communication skills, and inter-personal skills.
  • Works well under pressure, with initiative to take on unfamiliar tasks.
  • Great capability in managing projects, processes, and in depth understanding of drug development
  • Extensive Phase IV study design and publication supporting experiences

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