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Biostatistician

Company: Endologix, Inc.
Location: Irvine
Posted on: September 12, 2019

Job Description:

*

BIOSTATISTICIAN

Job ID

2019-2117

Location

US-CA-Irvine

Category

Medical Affairs

OVERVIEW

This position will utilize personal experience and technical expertise to support the Clinical Analytics team as we analyze, interpret, and present clinical and non-clinical data to stakeholders. Plan and lead the development of statistical solutions, analyses in SAS or comparable statistical software, and support data management. Support legacy studies and make contributions to new clinical studies that build evidence supporting the therapy.

RESPONSIBILITIES

Reviews and drafts Statistical Analysis Plans (SAPs) and develops SAS solutions for analysis of clinical data.

Determines sample sizes for new studies and appropriate statistical methodology

Assist in statistic model selection, experimental design, design and analysis of clinical trials

Analyze and interpret data from individual trials

Perform meta-analyses by pooling data from several studies

Initiate, plan, execute and manage all aspects of data analysis/management such as case report form design, define/program database/edit check specifications, assist in mid-study updates (MSU), contribute to the creation and maintenance of databases

Analyze clinical datasets within the SAS system and present results in a comprehensive and intuitive fashion to regulatory, clinical, and marketing audiences. Provide deliverables (tables/listings/graphs and interpretations) with an emphasis on quality and clarity for all regulatory submissions

Collaborate with R&D team for analysis and design of experiments for stent design and tolerances, polymer chemistry formulation and performance

Collaborate with Quality team for analysis of QC/Complaint trends as necessary

Collaborates with database developers on the design, documentation, testing and implementation of study database based on data management and protocol requirements.

Develops reports to track study progress to help the study team ensure timelines and quality expectations are met

Identify risks & mitigation actions for data management related deliverables

Maintain a broad understanding of current processes and methods as well as trends and directions of clinical data management and data analysis fields

Integrate databases from multiple studies or sources. Support summarization and transfer of databases to internal and external sources

Assists in data cleaning processes

Assist in validation of statistical suites (SAS) and statistical codes in accordance with regulatory standards and validation procedures

Develops and maintains good communications and working relationships with teams

Understands and complies with Standard Operating Procedures and Work Instructions. Assists in developing, revising, and maintaining data management standards, Operating Procedures and Work Instructions

Define and understands the data review requirements and processes to ensure delivery of the highest quality of data and the analyses based on this data

Performs other duties as directed by clinical analytics management

QUALIFICATIONS





* Minimum Education: Bachelor s degree in Statistics/Biostatistics, with training specific to SAS or other statistical language suites



* Minimum Experience: A minimum of 2 years of working experience analyzing clinical study data, data management activities, and solid familiarity with a statistical software suite such as SAS or R. Past work experience in a related regulated industry is a plus.



Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: Endologix, Inc., Irvine , Biostatistician, Other , Irvine, California

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