Senior Clinical Programmer

Location:  Brisbane, California Category: BioMetrics Employment Category: Fulltime-Temporary

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives. 
 

Duties


 



    • Programming



    • Develop and verify SAS programs to export data from EDC (electronic data capture)

    • Develop and verify SAS programs to import/export data to/from external vendors and internal special laboratories

    • Develop and verify SAS programs to produce data listings for ongoing studies

    • Participate in the review of programs, datasets and outputs written by programmers in Clinical Data Programming for quality and accuracy

    • Participate in supporting programming for the database interface (such as direct source reporting, edit checks, or custom programming)



    • Support programming for special projects as directed by Manager


 



    • Data quality



    • Work with other clinical programmers to ensure that data-related issues are communicated to the data manager in a timely manner

    • Assess and verify data quality prior to export and/or distribution to ensure quality, consistency and accuracy


 



    • Process



    • Adhere to established standard operating procedures (SOPs) and work instructions by the Clinical Data Programming group and Biometrics

    • Assist in documenting processes and practices of the Clinical Data Programming Group

    • Ensure that all clinical trials timeline-related tasks are documented by the completion date of the tasks, and verify with Manager and Clinical Data Manager regarding the completeness of the documentation for TMF filing purposes


 



    • Scheduling



    • Accept specifications and work with stakeholders to schedule the effective delivery of results

    • Provide status for scheduled, ongoing, and completed tasks in weekly Clinical Data Programming status meetings

    • Coordinate with other lead analysts and Manager to prioritize tasks based on resource requirements and timing of deliverables relative to all other studies

    • Negotiate with stakeholders regarding competing priorities if necessary


 



    • Other roles

    • Support other lead analysts as needed in the programming role and as a consultant for the lead analyst role



    • Take task and project direction from Clinical Data Programmer III, or Principal Clinical Data Programmer

    • Attend meetings internally or externally as directed by Manager, and may represent Clinical Data Programming group if necessary

Skills



    • 2-4 years experience and progressive application of SAS programming skills


 



    • 1-2 years experience in the following skill-sets:



    • Design and development of programming deliverables such as tables, figures, and listings

    • Creation of programs for quality control and completing quality control documentation

    • Utilizing MS Office suite, such as PowerPoint and Excel (DDE)

    • Taking end-to-end responsibility for tasks including ensuring quality results

    • Accessing, and processing database-related input and output

    • Database support programming (edit checks, SQL, reporting)



    • 2 years experience transforming SAS datasets into other structures such as text, CSV, XML, XLS, or HTML formats preferred

    • 2 years experience in the clinical trials/pharmaceutical setting preferred

    • 2 years experience in creating documentation for programming activities preferred



    • Knowledge of 1-2 languages or systems desirable


 



    • Good understanding in the following areas:



    • Relational database structures, standard software, and their implementation

    • Drug development process (Phase I through IV) and general regulatory requirements

    • Clinical coding conventions, coding dictionaries and MedDRA

    • ICH, GCP, and other regulations related to CDM and industry conventions



    • Experience with clinical datasets and databases preferred

    • Integration and interfacing skills utilizing MS Office suite preferred

    • Knowledge of software development lifecycle (SDLC) or other software development methodology preferred

    • Knowledge of lead programmer responsibilities and critical task scheduling preferred


 



    • Team-based skills:



    • Good organizational skills, with the ability to interact and communicate with stakeholders regarding timeline and task completion status

    • Good presentation skills

    • Good written and verbal communications skills

Education


.



    • Bachelor's Degree, preferably in Computer Science, Mathematics or other related scientific discipline



    • In lieu of a Bachelor’s Degree, completion of a certified relational database training program/course work or related web development program/course work, and six years (total) of relevant experience in data management or system validation

    •  



    • SAS Institute programming courses such as Base, and Advanced preferred; Macros optional



    • In lieu of these courses, 2 years experience as a SAS programmer and demonstrated skills


 



    • DBMS clinical trials database courses (Medidata Rave) preferred

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.

 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.