General Manager - München, Deutschland - Emmes

Beschreibung

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.

Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

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.

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,
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. 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.

Promotes staff participation and achieves a high degree of engagement across the global biostatistics department with a focus on staff supporting biopharma projects
MS or PhD in Biostatistics, Statistics, or Epidemiology
Typically has 12+years' experience with a PhD or 15+ years experience with a MS degree in a biostatistics environment
Management experience including interfacing with executive leadership and supervision of experienced biostatisticians and statistical programmers
Demonstrated leadership and project management experience.
Ability to lead and build effective teams and foster collaboration across broad groups or functions within the organization.
Strong interpersonal and communication skills required for interfacing with all levels of management.
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