Senior Biostatistician

Organization: 
Allergan
Job Location: 
Irvine, CA
Job Description: 

About Allergan:

Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life?s potential. Today, we have 11,000+ employees highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

About the Position:

The Sr. Biostatistician participates in the planning and execution of statistical tasks for assigned studies, including the preparation and maintenance of analysis plans, examination of data, performing statistical analyses, and ensuring quality - controlled production of tables, listings and graphs while adhering to the specifications and timelines. The position may serve on departmental teams.

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.

Principal Responsibilities:

Project Biostatistician

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.

QC Biostatistician

Performs quality control (QC) review of

- Randomization materials

- Analysis Plan and Table/Listing/Graph (TLG) Shells

- Topline and other TLGs

- Clinical documents and publication manuscripts.

- TLG files and Case Report Tabulation files in the Allergan electronic document management system (EDMS).

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.

Requirements:
Preferred candidates will have:

* Education or education/experience combination equivalent to a post graduate degree in statistics or statistics' related field. No pharmaceutical experience with a Ph.D. or Ph.D. equivalent. At least two (2) years of pharmaceutical experience with a master's degree or master's degree equivalent
* Knowledge and experience in computing tools such as SAS
* Statistical technical expertise including methodology, analysis, and design
* Statistical expertise with regard to clinical studies in one 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 essential skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, customer satisfaction
* Interpersonal skills
* Analytical and problem solving skills
* Flexible and well organized with the initiative to take on unfamiliar tasks and work well under pressure