Senior Clinical Programmer
3 days ago
The Senior Clinical Programmer (SCP) plays a pivotal role in supporting clinical research by developing, validating, and maintaining statistical programs and datasets. Collaborating with Biostatisticians, Clinical Data Managers, and cross-functional teams, the Senior Clinical Programmer ensures high-quality, timely deliverables that meet regulatory standards and study objectives. This role requires advanced SAS programming expertise, strong problem-solving skills, and the ability to mentor junior team members.
The SCP should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.
ESSENTIAL FUNCTIONS
- Program customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies.
- Analyze protocol, SAP, existing shells/templates as needed to understand structure and content of data.
- Prepare documentation for programs
- Prepare documentation describing all datasets and variables within, including derived variables, and the project as a whole.
- Create SAS datasets of clinical data from clinical databases
- Create status and efficacy datasets
- Create project-specific macros and formats
- Create study reports using SAS or Program R
- Load client data from other platforms and other software packages
- Prepare data to be sent to clients and as needed for other external transfers and data imports.
QUALIFICATIONS FOR ESSENTIAL FUNCTIONS
- Ability to communicate effectively in the English language in person, by phone and in writing.
- Ability to lead functional meetings.
- Strong attention to detail and accuracy is a must.
- Excellent organizational skills.
- Demonstrated ability to manage multiple projects.
- Ability to work collaboratively, effectively, and productively in diverse organization structures.
- Ability to work independently, take initiative and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication.
- Ability to work in a team-oriented, collaborative environment.
- Ability to work positively within a continually changing environment.
- Ability to effectively prioritize and execute tasks in a high-pressure environment.
- Advanced computer skills and practical knowledge of MS Office and potentially project management software.
EDUCATION AND EXPERIENCE REQUIRED
- A Bachelor's degree or equivalent combination of Education/Training/Experience is required. A degree in a scientific, medical, or technological discipline is preferred.
- A minimum of 3 years of clinical trial or clinical data management experience or similar industry experience/training is required.
- Prior trial responsibility for the entire data management life-cycle is desirable.
- Working knowledge of EDC studies is required and SAS is preferred.
WORK REQUIREMENTS
1. Cross-functional interactions.
TRAINING
- Complete Training Requirements per current Training Requirements List.
- Supervisor may assign additional skills training, one-on-one, see-one / do one, or other Training as necessary to achieve qualifications and improve job performance.
- Work alongside & learn from best in class talent
- Join a well known brand within Hospital / Health Care / Healthtech
- Flexible working options
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