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Jobs(26,572)/CRO Role(179)/ClinChoice (23) - 2027 Hiring Opportunities – Senior/Principal Statistical Programming(Remote in EU)
ClinChoice

ClinChoice - 2027 Hiring Opportunities – Senior/Principal Statistical Programming(Remote in EU)

European Union3w ago
In OfficePrincipalEMEAMedical DevicesPharmaceuticalsCROPrincipalReportingCROCoachingTimeline ManagementSAS

Requirements

• Collaborates 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. • Strong proficiency in SAS programming within a pharmaceutical, biotechnology, or CRO environment. • SAS programming • Strong understanding of CDISC standards, including SDTM and ADaM. • CDISC standards • Hands-on experience with SDTM and ADaM specification, development, and programming. • SDTM and ADaM specification, development, and programming • Strong experience in TFL programming and reporting. • TFL 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 experience in a pharmaceutical, biotechnology, or CRO environment supporting clinical development. • 8+ years of statistical programming experience • Experience in one or more of the following therapeutic areas is preferred: Oncology, Rare Disease, or Neuroscience. • Oncology, Rare Disease, or Neuroscience • R or other packages are desired; • Understand clinical data flow. Experience in NDA/sNDA submission is desired. • Education / Certifications (essential) • Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline • Language(s) (essential) • Language(s) (preferred) • Who will you be working for? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. • Our Company Ethos • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our low industry-average turnover rates.

Responsibilities

• Serve as a lead statistical programmer for multiple studies and/or compounds, ensuring high-quality and timely delivery of statistical programming activities. • lead statistical programmer • 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 for global regulatory submissions and responses to health authority questions. • global regulatory submissions • 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, including tables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML. • tables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML • Provide technical expertise in SAS programming, including development, QC/validation, and documentation of statistical programs. • SAS programming • Contribute to the development, implementation, and continuous improvement of SAS programming standards, SOPs, work instructions, and best practices. • SAS 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. • Provide technical guidance and mentoring to other statistical programmers and contribute to the development of programming capabilities within the organization. • technical guidance and mentoring to other statistical programmers • Identify opportunities to improve programming processes, adopt innovative and efficient approaches, and support evolving and complex study design methodologies. • Act as a subject matter expert in statistical programming and contribute to technical decision-making within assigned studies and therapeutic areas. • subject matter expert

Benefits

• Understand clinical data flow. Experience in NDA/sNDA submission is desired. • Education / Certifications (essential) • Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline • Language(s) (essential) • Language(s) (preferred) • Who will you be working for?

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