Senior Clinical Programmer

Location:  San Rafael, California Category: Data Science

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Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

Summary
The Senior Clinical Programmer role is responsible for performing clinical programming activities as delegated by the Program or Study Lead. The Senior Clinical Programmer role is responsible for executing clinical programming activities for assigned studies. This includes oversight of database builds, oversight of all clinical programming for data transfers, data validation, oversight and creation of system to system integrations and the generation of complete, correct and consistently fit-for-purpose operational datasets for data snapshot and data finalization activities.
The Senior Clinical Programmer will be an individual contributor and will not require any people management. This position will contribute to and make an impact on project or study team outputs.
 
Responsibilities
For an assigned study, the Senior Clinical Programmer may perform a range of the following responsibilities, depending upon the program complexity and program development stage:   
Data Management Clinical Programming Deliverable Development and Execution  

 

  • Collaborate with Data Manager to complete Data Validation Plans/Data Review Plans, including the definition of edit checks, data listings, and related analysis to ensure data collected in complete, in conformance with parameters and plausible. 

 

  • Review Data Transfer Specifications (DTS) and conduct clinical programming for import of third-party clinical data and related reconciliations. 
  • Conduct the programming and execution of Level 1 (edit checks by third party developers), Level 2 (clinical data review listings), and Level 3 (statistical data analysis / reviews) validation. 
  • Conduct Peer Review on Clinical Programming objects, listings, metrics, graphs, and data visualizations. 
  • Prepare operational, raw data for DB lock or snapshot 
    • Export data from EDC and import from external vendor; execute data quality checks; convert to SAS datasets; check for patient ID; ensure review and approval by Global Data Science stakeholders; lock permissions on folders for limited write access. 
Subject Matter Expertise 
    • Participate in initiatives aimed at expanding Global Data Science and Data Management capability in a designated area of expertise, such as ePRO, Artificial Intelligence (AI), Imaging, Real-World Evidence, etc. by building best practices in processes, tools, templates, or other guidance for the subject area.
 
Education & Experience
  • Degree in Statistics, Computer Science, or Life Sciences.
  • Master’s preferred; Bachelors acceptable with relevant experience
  • 2+ years’ experience with Master’s, or 5+ years with Bachelor’s degree
  • Relevant clinical development experience inclusive of technical and management experience within and outside of Data Management



Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

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.

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