Tech Observer is hiring Clinical Statistical Programmers in LATAM, UK and Europe on FSP.
About the Role
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.
Responsibilities
* 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.
Thorough understanding of 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.
Required Skills
* Advanced SAS programming expertise, strong problem-solving skills, and the ability to mentor junior team members.
* 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.
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.