Ofertes d'ocupació a AstraZeneca

• Nivell d'experiència---
• Tipus de contracteA temps complert
• PublicadaNova

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Role Barcelona onsite - 3 days at office/2 days at home

Statistical Science Associate Director in Cardiovascular, Renal and Metabolism

The Statistical Science Associate Director has sufficient experience working as a statistician in the pharmaceutical industry to independently perform and lead statistical work within a project, an indication within a more complexproject or complex studies. This individual is able to lead and direct Biometrics work either in house or partnering with CROs to ensure delivery to quality and time.

Typical Accountabilities:The Statistical Science Associate Director may work as a lead statistician

• For a project or indication in clinical therapeutic areas
• Leading the delivery and oversight on a multiple studies/indication within a project, potentially as a Global Project Statistician for a standard drug project
  
  

The Accountabilities For Supporting Projects Directly Include

• Lead the statistical thinking and contributions to the delivery of studies, development plans, regulatory strategy, health technology assessment and/or commercial activities
• Direct project work, including statistical staff and/or CRO partners, to ensure delivery to standards, quality and time
• Develop design options and provide high quality decision support to enable the business to make informed decisions about a study or project
• Quantify the benefit, risk, value and uncertainty of the emerging asset/product profile
• Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration, including modelling and simulation
• Mentor/coach and support the education and training of statistics staff
  
  

Education, Qualifications, Skills and Experience:Essential:

• MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc
• Strong knowledge of programming in R and/or SAS
• Knowledge of the technical and regulatory requirements related to the role
• Excellent communication skills and ability to build strong relationships
  
  

Desirable

• Project Management Skills
• Proficiency in SAS and R/Python languages
  
  

Date Posted

25-jun-2026

Closing Date

19-ago-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

• Nivell d'experiència---
• Tipus de contracteA temps complert
• Publicada25 de juny

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Introduction To Role

As a Clinical Research Associate (CRA) within AstraZeneca’s Oncology Cell Therapy Clinical Operations, you will have local responsibility for the delivery of clinical studies at assigned sites and serve as the primary point of contact for investigators and site staff. You will work closely with Local Study Teams and the Local Study Associate Director (LSAD) to ensure timely, high-quality execution in alignment with ICH-GCP, local regulations, and AstraZeneca procedural documents. Leveraging risk-based quality management principles, you will prepare, initiate, monitor, and close sites, ensuring inspection readiness and robust data quality across our innovative oncology cell therapy portfolio.

Accountabilities

• Site identification and start-up: Contribute to investigator/site selection. In applicable countries, lead start-up and regulatory maintenance, including qualification visits, dossier preparation, submissions to EC/IRB and Regulatory Authorities, and tracking essential documents.
• Training and inspection readiness: Train and advise investigators and site staff on protocol and RbQM. Confirm and document mandatory trainings (including ICH-GCP) and maintain inspection-ready site files at all times.
• Study conduct and performance: Initiate, monitor (onsite/remote), and close sites per Monitoring Plan and SOPs; share recruitment and site performance insights with Local Study Teams; proactively identify, resolve, and escalate study issues.
• Monitoring and data quality: Perform SDR, SDV, and CRF review; adapt monitoring intensity via regular Site Quality Risk Assessments; ensure timely query resolution and collaborate with data management for high-quality data.
• Safety and compliance: Secure accurate and timely reporting of SAEs and follow-ups; ensure compliance with AZ Code of Ethics, SOPs, ICH-GCP, data privacy requirements, and applicable legislation.
• Systems and documentation: Update CTMS and other systems per timelines; manage study supplies and drug accountability (including destruction preparation); prepare monitoring visit reports and follow-up letters; collect/upload essential documents to eTMF and support QC checks; ensure documentation is complete for archiving.
• Audit/inspection support: Prepare for and collaborate on audit and regulatory inspection activities with LSAD and Clinical Quality.
• Cross-functional collaboration: Work with LSADs, local medical teams (e.g., MSLs), and global study teams/vendors as directed; provide market and site intelligence relevant to oncology cell therapy studies.
  
  

Essential Skills/Experience

• Education: Bachelor’s degree in a related discipline (preferably life sciences) or equivalent qualification.
• Guidelines and regulations: Excellent knowledge of ICH-GCP; good knowledge of relevant local regulations; basic knowledge of GMP/GDP.
• Clinical operations: Solid understanding of clinical study management, including monitoring (onsite/remote), study drug handling, and data management; familiarity with risk-based monitoring and remote monitoring practices.
• Technical and analytical: Strong attention to detail; good analytical and problem-solving skills; ability to use e-enabled systems (CTMS, eTMF, EDC) and adapt to new technologies.
• Communication and collaboration: Good written and verbal communication; effective interpersonal and negotiation skills; ability to work with remote collaborators and in cross-functional teams.
• Delivery focus: Demonstrated ability to prioritize and manage multiple tasks with conflicting deadlines; proactive issue identification and resolution; ability to travel nationally/internationally as required.
• Professional conduct: Commitment to inspection readiness, patient safety reporting, data privacy, and adherence to AZ Code of Ethics and SHE requirements.
  
  

Desirable Skills/Experience

• Therapeutic area exposure: Medical knowledge and learning agility in oncology; interest or experience in cell therapy or advanced therapies.
• Process excellence: Experience championing efficiencies to deliver quality trials with reduced budget and timelines; change agility and continuous improvement mindset.
• Cultural awareness: Ability to work effectively across diverse sites and geographies.
• Additional qualifications: Valid driving license (where required by country); experience contributing to investigator meetings and audits/inspections; ability to support LSAD tasks as needed.
  
  

At AstraZeneca, we are driven by a vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in Oncology, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are empowered to lead at every level. We make bold decisions driven by patient outcomes, collaborating seamlessly with academia and industry to expedite research in some of the hardest-to-treat cancers. Join us in making a meaningful impact on millions of lives.

Ready to take the next step in your career? Apply now and become part of our dynamic team!

Date Posted

23-jun-2026

Closing Date

06-jul-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.