Biostatistician in Orange, California at KaVo Kerr

Date Posted: 5/11/2018

Job Snapshot

Job Description

Job ID: KAV001580

About Us

Kerr Corporation is a manufacturer of premiere dental consumables sold both domestically and internationally. Since 1891, Kerr has continued to build on its core competencies in developing innovative products for dental restorative procedures. With manufacturing, marketing and sales locations worldwide, Kerr is advancing esthetic dentistry through education and sustainable solutions for the clinician. Kerr's team spirited work environment encourages opportunities for personal and professional growth. Headquartered in Orange, CA., Kerr employs over 2,000 associates worldwide with manufacturing and administration offices located in the US, Switzerland, Czech Republic, and Italy.

Description

Position Summary:
As a member of the Clinical Affairs group team, the Biostatistician brings statistical expertise to the design, conduct, analysis and reporting of laboratory and clinical trials for new products at the pre- and post-marketing stages of products.   The Biostatistician works as a member of a cross-functional team and continuously strives to ensure timely delivery and scientific validity of results. He/she will work closely with the other functional areas such as marketing and quality to ensure seamless, accurate and timely delivery of trial results.
Essential Duties and Responsibilities:
  • Provide statistical input to study protocols for design and analysis of clinical and laboratory trials, randomizations, sample size calculations to determine power, and statistical analyses.
  • Prepares statistical analysis plans (SAPs), designs shells for tables, listings and figures and performs statistical analysis.
  • Contributes to the preparation and completion of clinical trial study documents including, but not limited to, study protocols, project specification plans, data management plans and clinical study reports.
  • Assists with the preparation of manuscripts and writes reports describing results of statistical analysis.
  • Help design customer satisfaction surveys, estimate reliability and validity of customer satisfaction surveys and knowledge in sampling methods.
  • Represents the Biostatistics function in project team meetings.
  • Consults with Project Development Team, Clinical Affairs Director and Product Managers on laboratory and clinical trial or statistical issues.
  • Provides consultation as needed on statistical method, questionnaire construction, and data gathering techniques.
  • Interfaces with project management, functional team members and investigators to ensure a timely, precise and accurate laboratory/clinical data reporting process.
  • Perform quality control checks on primary endpoints to validate results.
  • Work closely with engineering, manufacturing, quality and operations, teams on diverse range of projects to bring rigorous statistical analysis to bear in making technical and business decisions
  • Conducts all job duties within context of Good Clinical Practice (GCP) and according to company SOPs and applicable ICH/EMEA guidelines. 

Job Requirements



Qualifications

Qualifications:
  • A degree in biostatistics or statistics; Either a MS or PhD  with a minimum of 5 years of experience in clinical and laboratory l trials, preferably in a pharmaceutical or bio-engineering research organization environment.

Skills/Abilities:
  • Proficient in SAS programming for statistical analysis and data manipulations is essential;
  • Ability to understand and interpret complex mathematical/statistical problems.
  • Strong understanding of the product development process from design and inception to data acquisition to data reporting.
  • Experience in measuring customer satisfaction, survey design and statistical analysis methods.
  • Proficient with Microsoft Outlook, Word, and Excel; basic understanding of database programs is extremely helpful.
  • Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact and communicate with staff and management alike.
  • Ability to multi-task and interface with team members who are working under deadlines; ability to set priorities and good organizational planning, and time management skills.
  • Understanding of study protocols with ability to write clearly and concisely.

Physical Demands/Work Environment: 
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.

Kerr Corporation is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.


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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.5B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.