Principal Biostatistician (Finance)

About Dexcom:

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

Summary:

Responsible for creating, reviewing, and maintaining statistical analysis plans, performing statistical analysis, providing data interpretation and generating reports. These duties will be performed primarily in support of all clinical studies and regulatory submissions. Will lead effort in statistical aspects for scientific publications and presentations.

Essential Duties & Responsibilities:

• The incumbent will conduct the statistical analysis activities for all clinical trials, including but not limited to study design, statistical analysis plan, statistical programming, generate report (create tables, figures and listings, provide interpretations of the results, address limitations in study design and/or statistical method).
• The incumbent will perform statistical analysis for and regulatory documents submitted to regulatory agencies (US FDA and EU Commission), such as, but not limited to, IDEs, PMAs, 510ks or any supplemental submissions created.
• The incumbent will participate in operations meetings, address issues and represent the biostatistics unit at internal team meetings, with contract organizations and regulatory agencies, when neceassry.
• The incumbent will conduct statistical analyses and discussions for all abstracts and manuscripts created from clinical trial data and draft analyses findings and reports.
• The incumbent will provide leadership to junior biostatisticians in the team
• Additional duties will include statistical consultation to R&D, manufacturing, and marketing when necessary, review of CRF and data base structures, senior review of database locks and validation of statistical analyses macro/programs.
• Assumes and performs other duties as assigned.

Required Qualifications:

• Minimum of Master's degree (or equivalent) in Biostatistics or related field is required (PhD is preferred).
• At least 8 years of experience with MS degree or at least 5 years of experience with PhD in statistical analysis in clinical environments and biomedical industry, particularly in medical device industry, is required.
• Knowledge and experience in complex statistical methods, such as nonparametric analysis methods, non-ignorable missing data analysis, Bayesian analysis and/or adaptive study design, is highly valued.
• A working knowledge of SAS and strong statistical analysis skills are required. Knowledge in R, Python, or any other computer language skill is highly valued. Must be able to work with minimal oversight and work as a member of a project team.

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 13+ years related experience or a Master's degree and 8+ years equivalent industry experience of a PhD and 5+ years of experience.

Travel Required:

• None

Functional Description: Technical Individual Contributors

Performs the design, development, modification and evaluation of a technical infrastructure to expedite conduct and evaluation of clinical trials and basic research. Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical investigators to determine protocol design. Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility. Maintains expertise in state-of-the-art data manipulation and statistical analyses.

Functional/Business Knowledge:

• Possesses expert knowledge of leading technical areas.
• May be externally recognized as an expert in technical field.

Scope:

• High level of understanding of solving unique problems where analysis requires an in‐depth evaluation and may impact future concepts or technologies.

Judgement:

• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Demonstrates ability to discover and identify processes, novel science and technology which lead to increased productivity and results.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com.

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