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.
Performs the design, development, modification and evaluation of a technical infrastructure to expedite conduct and evaluation of the 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.
Essential Duties and Responsibilities
- The incumbent will generate statistical programming for all clinical trials, including but not limited to data validations, statistical analysis, and report generation (to create tables, figures and listings).
- Oversee programming activities by external vendors
- Provide input in developing CRF, database, data validation plan, and specifications of analysis datasets
- Review eCRF (EDC sytem) annotations and data specifications to provide input to Data Management Team for analysis needs
- Check for consistency and adequacy of eCRF and database (EDC System) for analysis needs
- Provide support to Data Management Team with their data validation plan or data management plan in later stages of product development or post-market studies
- Write or review analysis programs as specified in the protocol or the Statistical Analysis Plan (SAP)
- Write or modify efficient design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH, SAS/ETS, SAS/IML, and SAS MACROS
- Establish and monitor of data transfer specifications across different data environment for ongoing trials to identify study conduct or data quality issues
- Review or author statistical programming related Standard Operating Procedures or Working Instructions.
- Participate in operations meetings, address issues and represent the biostatistics team at meetings with cross-functional teams, contract organizations, and regulatory agencies, when necessary
- Assumes and performs other duties as assigned.
- At least 5 years of experience in statistical programming in clinical environments and biomedical industry is required.
- A working knowledge of templates utilities, such as SQL, and SAS, such as SAS advance, SAS macro, and SAS SQL are required. Data conversion knowledge and skills to/from various data format, such as xml, csv, excel and SAS, are required.
- Knowledge in R, Python, MatLab, 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.
Uses advanced mathematical and statistical concepts and theories to analyze and collect data and construct solutions to business problems. Performs complex statistical analysis on experimental or business data to validate and quantify trends or patterns identified by business analysts. Constructs predictive models, algorithms and probability engines to support data analysis or product functions; verifies model and algorithm effectiveness based on real world results. Designs experiments and methodologies to generate and collect data for business use. Projects may include a focus on "quantitative finance" or help identify new business opportunities.Functional/Business Knowledge
- Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
- Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Experience and Education
- Exercises good judgment in selecting methods and techniques for obtaining solutions.
- Normally receives little instruction on day-to-day work, general instructions on new assignments.
- Typically requires a Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
The annual base salary range for this role is $95,900.00 to $159,900.00. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.
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 email@example.com.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
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