04 nov
|
Jobgether
|
España
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Statistical Programmer based in Spain. We are seeking an experienced Senior Statistical Programmer to support and lead statistical programming activities across clinical research and development projects. In this role, you will contribute to the delivery of high-quality statistical outputs, ensuring accuracy, regulatory compliance, and adherence to project timelines. You will work extensively with SAS and CDISC standards, developing and validating SDTM and ADaM datasets, as well as statistical analysis outputs. Beyond hands-on programming, you will provide technical guidance, supervise team members, and help strengthen programming standards and processes. Collaborating with multidisciplinary international teams, you will contribute to the continuous improvement of clinical data workflows and project delivery. This is an excellent opportunity to make a meaningful contribution to healthcare and life sciences research within a integral, collaborative, and innovation-driven environment. Accountabilities:
- Support and lead statistical programming activities across clinical research projects, ensuring the timely delivery of accurate, high-quality programming outputs.
- Specify, develop, program, and validate CDISC-compliant SDTM and ADaM datasets in accordance with applicable industry standards.
- Develop and validate statistical analysis outputs, including analysis datasets, tables, listings, and figures (TLFs).
- Prepare, review, and maintain statistical programming documentation and other relevant CDISC deliverables.
- Create, validate, and maintain clinical trial randomization lists, ensuring accuracy and compliance with established procedures.
- Ensure that all statistical programming activities comply with internal Standard Operating Procedures (SOPs), quality standards, and relevant regulatory requirements.
- Monitor and report process deviations, key performance indicators (KPIs), customer complaints, and corrective and preventive actions (CAPAs).
- Supervise statistical programming tasks and provide technical guidance to programming team members on established procedures, methodologies, and technical standards.
- Support resource planning and allocation to ensure efficient project execution and balanced team workloads.
- Prepare and deliver internal and external training sessions covering statistical programming techniques, tools, and best practices.
- Identify, evaluate, and implement innovative programming techniques, solutions, tools, and products to enhance project efficiency and quality.
- Identify opportunities for process optimization and operational improvement across statistical programming activities.
- Lead internal initiatives aimed at improving departmental workflows, technical standards, and overall programming efficiency.
- Maintain effective communication with internal and external project stakeholders, ensuring alignment on deliverables, priorities, and timelines.
- Escalate technical challenges, project risks, and delivery issues to Project Managers or Associate Directors within appropriate timeframes.
- Collaborate with Quality Assurance teams during internal audits and support the implementation of relevant quality improvements.
- Undertake additional statistical programming responsibilities as required to support clinical project objectives.
Requirements:
- Bachelor's or Master's degree, or equivalent academic and professional experience, preferably in Statistics, Mathematics, Computer Science, or a related discipline.
- At least 3 years of professional experience in statistical programming, preferably within clinical research, pharmaceutical, biotechnology, or medical technology environments.
- Excellent SAS programming skills, with the ability to develop, validate, and troubleshoot complex statistical programming deliverables.
📌 Senior Statistical Programmer (España)
🏢 Jobgether
📍 España