Head of Biopharma Biostatistics

vor 6 Monaten

Munich, Deutschland Emmes Vollzeit

Overview:
**Head of Biopharma Biostatistics - Remote**

**Germany Remote**

The Emmes Company, LLC (“Emmes”) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients’ success by sharing ideas openly and honestly.

**Primary Purpose**

The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes’ biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others. The Head of Biopharma Biostatistics serves as a member of Emmes’ biopharma leadership team ensuring high-quality, on time, and on budget statistical deliverables and supporting business development activities for potential biopharma opportunities.

**Responsibilities**:

- Designs clinical development plans, clinical trial protocols, and statistical analysis plans in collaboration with our biopharma partners.
- Leads and oversees statistical deliverables including but not limited to execution of statistical analyses, interim safety and efficacy reports, clinical study reports, and scientific manuscript development.
- Fosters collaborative relationship with Sponsors and Emmes project team members serving as a point of contact for project statistical deliverables,
- Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings)
- Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC)
- Attends and presents at external statistical conferences and workshops serving as a thought leader in the biostatistics space.
- Proactively uses knowledge of advanced biostatistical methodology and leading industry trends to identify and implement biostatistical best practices.
- Responsible for successful delivery of biostatistics and statistical programming services to Emmes’ biopharma clients overseeing budget, timelines, and quality of biostatistics related deliverables.
- Collaborates with global department leadership to ensure sufficient resourcing to support Emmes’ biopharma portfolio
- Serves as an escalation point for biostatistics related client, quality or budget concerns for biopharma projects, resolving concerns or appropriately escalating to global biostatistics and biopharma leadership.
- Leads statistical only or limited scope projects including managing budgets, timelines, deliverables, and change orders
- Leads biopharma related business development activities on behalf of the global biostatistics department including but not limited to proposal, budget development, and bid defense support.
- Represents the global biostatistics department as a member of Emmes’ biopharma leadership team and serves as a member of the global biostatistics leadership team.
- Provides input into professional development and technical training standards for the global biostatistics department
- Independently leads cross-functional interactions and initiatives with other departments and global entities ensuring frequent, clear and open communication with groups outside the global biostatistics department.
- Effectively supervises biostatistics and statistical programming staff providing mentorship, feedback and conducting performance reviews
- Participates in recruiting activities for new biostatistics department staff and contributes to hiring decisions.
- Promotes staff participation and achieves a high degree of engagement across the global biostatistics department with a focus on staff supporting biopharma projects
- Proactively identifies high-performing staff and provides them with mentorship and opportunities for career growth
- Other duties as assigned

Qualifications:

- MS or PhD in Biostatistics, Statistics, or Epidemiology
- Typically has 12+years’ experience with a PhD or 15+ years

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