Senior Clinical Programmer

  • location: Brisbane, CA
  • type: Contract
  • salary: $40.26 - $47.36 per hour
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job description

Senior Clinical Programmer

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!

 
location: Brisbane, California
job type: Contract
salary: $40.26 - 47.36 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
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
 
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
  • 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 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
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
 
skills: SOP, SAS/STAT, GCP (Good Clinical Practice), SDLC, EDC (Electronic Data Capture), Biostatistical Analysis, ICH Regulations, MedDRA
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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