Senior Statistical Programmer

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.
Strong knowledge of CDISC standards, particularly SDTM and ADaM, and their application in clinical research.
Good understanding of clinical research principles, statistical programming methodologies, and clinical trial data requirements.
Experience producing and validating statistical analysis datasets, tables, listings, and figures is highly desirable.
Familiarity with R programming is considered an advantage.
Understanding of clinical trial randomization processes and associated programming requirements is beneficial.
Good knowledge of Microsoft Office applications and standard professional documentation tools.
Good English communication skills, both written and verbal, with the ability to collaborate effectively in an international working environment.
Strong analytical and problem-solving abilities, with excellent attention to detail and a commitment to delivering accurate, high-quality work.
Demonstrated ability to prioritize responsibilities, manage competing deadlines, and maintain productivity across multiple projects.
Leadership skills, including the ability to supervise colleagues, delegate tasks, provide technical guidance, and support team development.
Reliable, accountable, and quality-focused approach to professional responsibilities.
Collaborative mindset, with the ability to work effectively within multidisciplinary and geographically distributed teams.
Curiosity and willingness to learn, adopt new technologies, and continuously improve existing practices.
Innovative thinking and a proactive approach to identifying opportunities for technical and operational improvements.
Benefits:
Fully remote working opportunity across Europe, offering flexibility in your working location.
Full-time professional engagement within an international healthcare and life sciences environment.
Opportunity to contribute to clinical research projects and support the development of innovative healthcare solutions.
Collaboration with a global multidisciplinary team of scientists, statisticians, clinicians, and industry experts representing diverse professional and cultural backgrounds.
Professional development opportunities, including access to learning initiatives and technical training.
Exposure to international clinical research projects and opportunities to collaborate with global clients and teams.
Flexible working programs designed to support different working arrangements and individual needs.
Opportunities for international travel and cross-border professional collaboration, depending on project requirements.
An innovative and collaborative working culture that encourages initiative, accountability, knowledge sharing, and continuous improvement.
Compensation determined according to the applicable location-specific salary range, taking into account the candidate's confirmed work location, professional experience, skills, qualifications, internal equity, and the scope of the role.