Principal Statistician
Hace 2 días
Bilbao, País Vasco, España
Warman O'Brien
Jornada completa
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We are partnering with a leading global CRO to recruit an experienced Principal Biostatistician to join their growing biometrics team. This is an excellent opportunity for a Principal Biostatistician looking to take on a highly visible role, providing statistical leadership across complex global clinical trials while working closely with pharma and biotech clients. You will lead studies and regulatory submissions, collaborate with cross-functional teams and external stakeholders, mentor junior statisticians, and play a key role in delivering high-quality clinical development programmes. This is a fully home-based position (Poland, Spain, Romania, Bulgaria, Czech Republic or Hungary). What you will be doing:
* Lead biostatistics activities across individual studies, programmes of studies and regulatory submissions
* Provide statistical leadership and oversight throughout the clinical development lifecycle
* Review and approve study protocols, Statistical Analysis Plans (SAPs), clinical study reports and other key statistical deliverables
* Collaborate with sponsors, project teams and regulatory agencies to ensure high-quality study delivery
* Provide statistical consultancy to support proposal development, project planning and budgeting
* Participate in bid defence meetings and client presentations, representing the biostatistics function
* Mentor and support junior statisticians while promoting best practices across projects
* Ensure all statistical deliverables are produced to the highest quality and in accordance with regulatory requirements What you will need:
* MSc or PhD in Biostatistics, Statistics or a related discipline
* 7+ years' experience (PhD) or 9+ years' experience (MSc) within clinical biostatistics
* Extensive experience supporting Phase I-IV clinical trials within a pharma or CRO environment
* Strong knowledge of statistical methodologies, clinical trial design and the drug development process
* Experience leading multiple studies, submissions or clinical programmes
* Excellent communication and stakeholder management skills with proven leadership experience
* Ability to work effectively across cross-functional and international project teams What's in it for you:
* Competitive salary and comprehensive benefits package including medical, dental, vision, pension and life insurance
* Fully home-based in Poland, Spain, Romania, Bulgaria, Czech Republic or Hungary
* Excellent long-term career development and progression opportunities
* Structured learning and development programmes
* Opportunity to work on innovative global clinical development programmes within a collaborative and supportive environment #J-18808-Ljbffr
* Lead biostatistics activities across individual studies, programmes of studies and regulatory submissions
* Provide statistical leadership and oversight throughout the clinical development lifecycle
* Review and approve study protocols, Statistical Analysis Plans (SAPs), clinical study reports and other key statistical deliverables
* Collaborate with sponsors, project teams and regulatory agencies to ensure high-quality study delivery
* Provide statistical consultancy to support proposal development, project planning and budgeting
* Participate in bid defence meetings and client presentations, representing the biostatistics function
* Mentor and support junior statisticians while promoting best practices across projects
* Ensure all statistical deliverables are produced to the highest quality and in accordance with regulatory requirements What you will need:
* MSc or PhD in Biostatistics, Statistics or a related discipline
* 7+ years' experience (PhD) or 9+ years' experience (MSc) within clinical biostatistics
* Extensive experience supporting Phase I-IV clinical trials within a pharma or CRO environment
* Strong knowledge of statistical methodologies, clinical trial design and the drug development process
* Experience leading multiple studies, submissions or clinical programmes
* Excellent communication and stakeholder management skills with proven leadership experience
* Ability to work effectively across cross-functional and international project teams What's in it for you:
* Competitive salary and comprehensive benefits package including medical, dental, vision, pension and life insurance
* Fully home-based in Poland, Spain, Romania, Bulgaria, Czech Republic or Hungary
* Excellent long-term career development and progression opportunities
* Structured learning and development programmes
* Opportunity to work on innovative global clinical development programmes within a collaborative and supportive environment #J-18808-Ljbffr