06 nov
|
Jobgether
|
Málaga
This is a senior-level opportunity within a global clinical research environment where statistical expertise directly contributes to the development of life-changing therapies. In this role, you will support clinical trials from protocol design through study completion, ensuring the integrity, quality, and scientific validity of statistical outputs. You will collaborate closely with cross-functional teams including clinical, programming, and regulatory experts, playing a key role in shaping study design and analysis strategies. You will also contribute to the development of statistical analysis plans, oversight of deliverables, and interpretation of clinical trial data. This role is idóneo for an experienced statistician seeking to influence global drug development programs while mentoring peers and ensuring the highest standards of analytical rigor. Develop Statistical Analysis Plans (SAPs), including mock tables, listings, and figures, ensuring clarity and alignment with study objectives and regulatory expectations. Oversee and review statistical programming outputs, including analysis datasets, tables, listings, and figures for accuracy and compliance with specifications. Collaborate with sponsors and cross-functional teams to ensure robust study design and high-quality statistical deliverables. Conduct quality control and verification of study outputs, ensuring alignment with SAPs, protocols, and regulatory standards. Serve as a biostatistics representative on study teams, contributing to project planning, meetings, and cross-functional discussions. Monitor project timelines, manage multiple studies concurrently, and proactively escalate risks or delays when necessary. Support regulatory interactions, data monitoring committees, and integrated analyses when required. Contribute to business development activities, including proposal development, budgeting, and bid defense meetings.
Mentor and coach junior biostatistics staff, supporting knowledge sharing and capability development. Advanced degree (Master's or PhD) in Statistics, Biostatistics, Mathematics, or a related quantitative field. Extensive experience as a statistician in clinical trials within the pharmaceutical, biotech, or CRO industry. Strong expertise in statistical methodology applied to clinical research, including study design, analysis planning, and interpretation of results. Experience preparing Statistical Analysis Plans (SAPs), clinical trial protocols, and regulatory submission documentation. Proficiency in SAS programming and familiarity with clinical trial data structures, analysis datasets, and reporting outputs. Experience contributing to regulatory submissions, DSMB/DMC activities, or integrated analyses is highly desirable. Fluency in English, both written and spoken. Competitive compensation package aligned with senior-level expertise in clinical statistics. Flexible working arrangements across EMEA, including remote options. Opportunity to work on global clinical trials contributing to innovative drug development programs. Exposure to regulatory interactions and high-impact clinical research activities. Career development and progression opportunities within a global life sciences environment. Collaborative, science-driven culture with strong cross-functional teamwork. Involvement in high-profile studies spanning multiple therapeutic areas and geographies. Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). If you would like more information about how your data is processed, please contact us.
📌 Statistician (Málaga)
🏢 Jobgether
📍 Málaga