欧盟生物统计学主管

Mylan Pharma UK LimitedViatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Every day, we rise to the challenge to make a difference, and here’s how the Senior Director Biostatistics role will make an impact:
This role offers the opportunity to shape the statistical strategy behind innovative clinical development programs, directly influencing study design, regulatory submissions, and key development decisions, while leading and developing a global team of statisticians and strengthening the strategic impact of Biostatistics across the organization.
Key responsibilities for this role include:

• Provide strategic statistical leadership for clinical development programs and studies from design through regulatory submissions and lifecycle management.

• Lead, inspire, and coach a small global team of Statisticians.

• Lead the statistical design, analysis, interpretation and communication of clinical trial data.

• May act as a senior Principal Statistician for key development projects when required

• Review protocols, SAPs, CSRs, and provide guidance on regulatory submissions, briefing documents and responses to requests from health authorities.

• Oversee statistical deliverables, ensure quality, consistency and timely execution.

• Ensure compliance with regulatory requirements, GCP, ICH guidelines and company standards.

• Partner with cross-functional stakeholders and represent Biostatistics in strategic discussions.

• Drive capability building and innovation to meet current and future business needs

• Increase the visibility and impact of Biostatistics internally and externally through joint authorship on publications and presentations.

The minimum qualifications for this role are:
The ideal candidate is an inclusive people leader with a proactive and collaborative mindset, and comfortable operating in a complex, cross functional environment and able to lead by example as hands-on senior principal statistician.

• PhD or Master’s degree in Statistics, Biostatistics, Mathematics, or related field.

• Substantial experience of clinical drug development within pharmaceutical, biotechnology, or CRO

• Extensive biostatistical experience as project statistician or principal statistician within the pharmaceutical industry across multiple therapeutic areas

• Strong experience supporting Phase II–IV clinical trials and regulatory submissions.

• Experience leading, mentoring and developing statisticians in a global pharma or CRO environment fostering scientific excellence.

• A demonstrable record of collaboration on external publications preferred.

Technical Skills

• Deep understanding of clinical trial statistical methodologies.

• Proficiency in SAS and/or R

• Knowledge of CDISC standards including SDTM and ADaM and electronic submission standards and regulatory review processes.

• A thorough understanding of global regulatory submission expectations, and a proven record of direct interaction with regulatory agencies at a senior level.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
Originally posted on Himalayas