Biostatistician And Sas Programmer
hace 2 semanas
Overview: We are seeking a highly skilled and experienced Senior Clinical Data Programmer to join our dynamic team.
The successful candidate will be responsible for overseeing the programming and validation of clinical trial databases, ensuring data accuracy, integrity, and compliance with regulatory standards.
This role requires a strong background in programming languages such as SAS, along with in-depth knowledge of clinical data management processes and industry best practices to support document creation.
Responsibilities: Database Programming: Lead the development and implementation of clinical trial databases using SAS programming language, adhering to study protocols, statistical analysis plans, and regulatory requirements.
Quality Assurance: Perform thorough validation and quality control checks on programmed datasets to ensure accuracy, consistency, and compliance with internal standards and regulatory guidelines.
Data Transformation: Utilize advanced programming techniques to transform and manipulate raw clinical data from various sources into formats suitable for analysis and reporting.
Documentation: Create and maintain comprehensive documentation of programming activities, including annotated SAS code, data specifications, and validation plans, to support regulatory submissions and audit readiness.
Collaboration: Collaborate closely with cross-functional teams, including Clinical Operations, Biostatistics, and Regulatory Affairs, to address data-related issues, provide technical expertise, and support study objectives.
Process Improvement: Identify opportunities to streamline data management processes, enhance programming efficiencies, and implement innovative solutions to optimize study timelines and deliverables.
Mentorship and Training: Provide guidance and mentorship to junior team members, fostering their professional development and promoting a culture of continuous learning and excellence.
Qualifications: Bachelor's or Master's degree in Computer Science, Statistics, Bioinformatics, or a related field.
Minimum of 5 years of experience in clinical data programming within the pharmaceutical, biotechnology, or CRO industry.
Proficiency in SAS programming language, with demonstrated expertise in data manipulation, analysis, and reporting (SAS Base, SAS Macro, SAS SQL).
Strong understanding of clinical trial data standards (CDISC), data management processes, and regulatory requirements (FDA, EMA, ICH).
Excellent problem-solving skills and attention to detail, with the ability to troubleshoot and resolve complex data issues independently.
Effective communication and interpersonal skills, with the ability to collaborate effectively in a cross-functional team environment.
Proven leadership experience, including the ability to mentor and coach junior team members, prioritize tasks, and manage multiple projects simultaneously.
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