Senior Clinical Programmer

Brisbane, CA 94005

Posted: 07/01/2019 Employment Type: Contract Industry: Clinical & Scientific Job Number: 15998

Bayside Solutions is seeking a Senior Clinical Programmer to be part of our client’ s team in Brisbane. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.

Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

Senior Clinical Programmer

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.

Summary of Responsibilities:
  • 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
  • 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
  • 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
  • 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
  • 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

Summary of Qualifications:
  • 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
  • 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
  • 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
  • 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

Ethan Christenson
Scientific Recruiter

If you are looking for career growth or new opportunities you have come to the right place! Here at Bayside solutions we specialize in relationship based recruiting, we are focused and determined to take your career in the direction you want it to go. I would love to talk to you about your career objectives, sports, traveling, or anything else that interests you. I look forward to getting to know you and where you want to go!
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