Founded in 1950, Allergan, Inc. (NYSE: AGN) is a global multi-specialty health care company headquartered in Southern California with rapidly growing annual revenues of $5+ billion. The company’s two primary segments are specialty pharmaceuticals and medical devices. Allergan's flagship franchises in eye care, neurosciences, medical dermatology and urologics, structured under Allergan Pharmaceuticals, offer specialty physicians and their patients a wide range of treatments to help preserve and protect sight, reduce physical disability and enhance quality of life. In 2006, Allergan added aesthetics and dermal fillers to its business portfolio to create a world-leading medical aesthetics franchise. At the same time, Allergan added a leading product portfolio in obesity intervention that offers minimally invasive devices to help patients achieve sustained weight loss and reduce health risks associated with obesity.
About the Position:
The Principal Biostatistician position serves essential roles of a project biostatistician and represents BSP in teams of assigned projects or studies. The position collaborates with team members in developing protocols and case report forms, plans all aspects of data analysis for assigned projects or studies, has responsibility for the preparation, maintenance and execution of the Analysis Plan (AP), and ensures the quality-controlled production of all tables, listings and graphs while adhering to timelines. This position may serve on company and/or departmental teams and make recommendations for departmental standards.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives
Represents BSP on project/study teams and coordinates/communicates with management and other team members regarding project/study status and budget/timeline update. Consults on clinical development plan and collaborates on study synopsis/protocol to ensure proper design, sample size and key planned analyses. Ensures generation of accurate randomization schedules. Collaborates on developing case report forms to ensure quality data collection.
Plans and coordinates statistical analyses for assigned project/study. Prepares and maintains (or supervises the preparation and maintenance of) the Analysis Plan (AP), including that for the Data Review Committee (DRC). Ensures consistency in statistical methodology, programming standards, and data specifications with all studies in the same project. Reviews specification documents in data collection, integration, and clean-up to ensure quality of data.
Provides statistical leadership in the execution of planned and exploratory analyses. Ensures the quality-controlled production of all tables, listings and graphs for clinical documents (Clinical Study Report, ISS/ISE, CTD) and publication manuscripts. Collaborates on reporting of results, including the writing or input to the writing regarding statistical analyses
General Compliance and Other Role
The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and work instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.
Preferred candidates will have:
Education or education/experience combination equivalent to a post graduate degree in statistics or statistics-related field. At least two (2) years of pharmaceutical experience with the Ph.D. or Ph.D. equivalent. At least four (4) years of pharmaceutical experience with a master's degree or master's degree equivalent.
Knowledge of global regulatory guidance documents and requirements
Statistical technical expertise including methodology, analysis, and design
Knowledge and experience in computing tools such as SAS
Statistical expertise with regard to clinical studies in two or more topics in each of the Design and Analysis/Methodology categories listed in the following:
Design – crossover design, parallel design, adaptive design, superiority/non-inferiority/equivalence hypothesis testing, controlling for multiplicity, designing and implementing interim analyses, sample size and power calculations, bioequivalence and bioavailability
Analysis/Methodology – linear models, non-linear modeling, survival analysis, categorical data analysis, multivariate analysis, nonparametric techniques, longitudinal analysis, meta analysis, data mining, simulation, robust estimation, reliability, missing value imputation, PK/PD, analysis of microarrays.
Competencies and skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, customer satisfaction
Analytical and problem solving skills
Flexible and well organized with the initiative to take on unfamiliar tasks and work well under pressure