2027 Hiring Opportunities – Senior/Principal Statistical Programming(Remote In Eu)
Hace 2 días
Madrid, España
ClinChoice
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Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
We are building our talent pipeline for 2027 and expect to have multiple opportunities throughout the year for experienced professionals in Clinical Statistical Programming at the Senior and Principal level.
We anticipate hiring for up to 20 positions during calendar year 2027, with openings becoming available at different times based on client demand and business growth.
TheSenior/Principal Statistical Programmeris responsible for serving as a technical and study programming lead across multiple compounds and/or studies within the Statistical Programming function, supporting Ipsen’s assets within a specific therapeutic area such asOncology, Rare Disease, or Neuroscience .
The role requires strong hands-on statistical programming expertise, study leadership, and technical knowledge to ensure the quality, consistency, and timely delivery of statistical programming activities. The programmer will work closely with statisticians, clinical teams, data management, and other cross-functional stakeholders and may also provide technical oversight of outsourced programming activities.
Main Responsibilities & Technical CompetenciesServe as alead statistical programmerfor multiple studies and/or compounds, ensuring high-quality and timely delivery of statistical programming activities.
Lead and execute statistical programming activities across clinical trials, from study start-up through database lock, reporting, and regulatory submission.
Ensure consistency, quality, and executional excellence across programming deliverables for assigned studies.
Support programming activities forglobal regulatory submissionsand responses to health authority questions.
Provide technical oversight and guidance for outsourced statistical programming activities, ensuring deliverables meet required quality, budget, and timeline expectations.
Develop, review, and validate high-quality statistical programming deliverables, includingtables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML .
Provide technical expertise inSAS programming, including development, QC/validation, and documentation of statistical programs.
Contribute to the development, implementation, and continuous improvement ofSAS programming standards, SOPs, work instructions, and best practices .
Ensure study-related programming documentation is maintained in accordance with Ipsen processes and is inspection/audit ready.
Collaborate with statisticians and cross-functional teams to understand complex study designs, endpoints, and analysis requirements and translate them into robust programming solutions.
Providetechnical guidance and mentoring to other statistical programmersand contribute to the development of programming capabilities within the organization.
Identify opportunities to improve programming processes, adopt innovative and efficient approaches, and support evolving and complex study design methodologies.
Act as asubject matter expertin statistical programming and contribute to technical decision-making within assigned studies and therapeutic areas.
Behavioural Competencies RequiredCollaborates effectively across functions and organizational boundaries.
Communicates clearly with both technical and non-technical stakeholders.
Proactively seeks relevant stakeholder input and expertise to support effective decision-making.
Takes ownership and accountability for decisions, actions, successes, and challenges.
Demonstrates strong planning and organizational skills, effectively managing priorities, resources, and timelines.
Maintains a strong focus on quality, compliance, and timely execution.
Demonstrates a proactive approach to identifying risks, resolving issues, and driving continuous improvement.
Supports and coaches colleagues by sharing technical knowledge and best practices.
Knowledge & ExperienceStrong proficiency inSAS programmingwithin a pharmaceutical, biotechnology, or CRO environment.
Strong understanding ofCDISC standards, including SDTM and ADaM.
Hands-on experience withSDTM and ADaM specification, development, and programming .
Strong experience inTFL programming and reporting .
Experience supporting clinical trial reporting and/or regulatory submissions.
Experience working with complex clinical trial data and study designs.
Ability to provide technical leadership and independently manage programming activities across multiple studies.8+ years of statistical programming experiencein a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
Experience in one or more of the following therapeutic areas is preferred:Oncology, Rare Disease, or Neuroscience .
Knowledge & Experience (preferred)R or other packages are desired; Understand clinical dataflow. Experience in NDA/sNDA submission is desired.
Education / Certif
We are building our talent pipeline for 2027 and expect to have multiple opportunities throughout the year for experienced professionals in Clinical Statistical Programming at the Senior and Principal level.
We anticipate hiring for up to 20 positions during calendar year 2027, with openings becoming available at different times based on client demand and business growth.
TheSenior/Principal Statistical Programmeris responsible for serving as a technical and study programming lead across multiple compounds and/or studies within the Statistical Programming function, supporting Ipsen’s assets within a specific therapeutic area such asOncology, Rare Disease, or Neuroscience .
The role requires strong hands-on statistical programming expertise, study leadership, and technical knowledge to ensure the quality, consistency, and timely delivery of statistical programming activities. The programmer will work closely with statisticians, clinical teams, data management, and other cross-functional stakeholders and may also provide technical oversight of outsourced programming activities.
Main Responsibilities & Technical CompetenciesServe as alead statistical programmerfor multiple studies and/or compounds, ensuring high-quality and timely delivery of statistical programming activities.
Lead and execute statistical programming activities across clinical trials, from study start-up through database lock, reporting, and regulatory submission.
Ensure consistency, quality, and executional excellence across programming deliverables for assigned studies.
Support programming activities forglobal regulatory submissionsand responses to health authority questions.
Provide technical oversight and guidance for outsourced statistical programming activities, ensuring deliverables meet required quality, budget, and timeline expectations.
Develop, review, and validate high-quality statistical programming deliverables, includingtables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML .
Provide technical expertise inSAS programming, including development, QC/validation, and documentation of statistical programs.
Contribute to the development, implementation, and continuous improvement ofSAS programming standards, SOPs, work instructions, and best practices .
Ensure study-related programming documentation is maintained in accordance with Ipsen processes and is inspection/audit ready.
Collaborate with statisticians and cross-functional teams to understand complex study designs, endpoints, and analysis requirements and translate them into robust programming solutions.
Providetechnical guidance and mentoring to other statistical programmersand contribute to the development of programming capabilities within the organization.
Identify opportunities to improve programming processes, adopt innovative and efficient approaches, and support evolving and complex study design methodologies.
Act as asubject matter expertin statistical programming and contribute to technical decision-making within assigned studies and therapeutic areas.
Behavioural Competencies RequiredCollaborates effectively across functions and organizational boundaries.
Communicates clearly with both technical and non-technical stakeholders.
Proactively seeks relevant stakeholder input and expertise to support effective decision-making.
Takes ownership and accountability for decisions, actions, successes, and challenges.
Demonstrates strong planning and organizational skills, effectively managing priorities, resources, and timelines.
Maintains a strong focus on quality, compliance, and timely execution.
Demonstrates a proactive approach to identifying risks, resolving issues, and driving continuous improvement.
Supports and coaches colleagues by sharing technical knowledge and best practices.
Knowledge & ExperienceStrong proficiency inSAS programmingwithin a pharmaceutical, biotechnology, or CRO environment.
Strong understanding ofCDISC standards, including SDTM and ADaM.
Hands-on experience withSDTM and ADaM specification, development, and programming .
Strong experience inTFL programming and reporting .
Experience supporting clinical trial reporting and/or regulatory submissions.
Experience working with complex clinical trial data and study designs.
Ability to provide technical leadership and independently manage programming activities across multiple studies.8+ years of statistical programming experiencein a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
Experience in one or more of the following therapeutic areas is preferred:Oncology, Rare Disease, or Neuroscience .
Knowledge & Experience (preferred)R or other packages are desired; Understand clinical dataflow. Experience in NDA/sNDA submission is desired.
Education / Certif