Senior Statistical Programmer

Jobgether

Ireland

On-site

EUR 90,000 - 120,000

Full time

3 days ago
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Job summary

Jobgether, on behalf of a partner company, seeks a Senior Statistical Programmer based in Ireland to lead statistical programming activities across clinical research projects, ensuring timely delivery of high-quality outputs. The role emphasizes SAS programming and CDISC standards (SDTM/ADaM) with development of analysis datasets and TLFs.

You will supervise colleagues, validate outputs, prepare documentation, and engage with QA during audits, while coordinating with cross-functional teams in an

Qualifications

  • Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or related discipline.
  • At least 3 years of professional experience in statistical programming, preferably in clinical research or related fields.
  • Excellent SAS programming skills with ability to develop, validate, and troubleshoot complex outputs.
  • Strong knowledge of CDISC SDTM and ADaM and their application in clinical trials.
  • Experience producing and validating SAS datasets, tables, listings, and figures is desirable.
  • Familiarity with R is an advantage.
  • Good English communication skills and ability to collaborate in an international environment.
  • Leadership skills to supervise colleagues and guide team development.
  • Detail-oriented with ability to prioritize deadlines across multiple projects.

Responsibilities

  • Support and lead statistical programming activities across clinical research projects, ensuring timely delivery of high-quality outputs.
  • Specify, develop, program, and validate CDISC-compliant SDTM and ADaM datasets.
  • Develop and validate statistical analysis outputs, including TLFs.
  • Prepare, review, and maintain statistical programming documentation and CDISC deliverables.
  • Create, validate, and maintain randomization lists.
  • Ensure SOPs and quality standards meet regulatory requirements.
  • Monitor KPIs, customer feedback, and CAPAs; escalate as needed.
  • Supervise programming tasks and guide team members.
  • Support resource planning and allocation for efficient project execution.
  • Prepare and deliver training sessions on programming techniques and tools.
  • Identify and implement innovative techniques and tools to improve efficiency.
  • Lead internal initiatives to improve workflows and standards.
  • Maintain effective communication with stakeholders and manage escalation of risks.
  • Collaborate with QA during audits and support quality improvements.
  • Undertake additional programming responsibilities as required.

Skills

Leadership
English communication
Analytical skills
Attention to detail
Prioritization
Team collaboration

Education

Bachelor's or Master's in Statistics/Mathematics/CS or related

Tools

SAS
R
CDISC (SDTM/ADaM)
Microsoft Office

Job description

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 Ireland.

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.

  • 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.
  • 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.
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