Associate Director Biostatistics
vor 2 Monaten
**Salary**:
Highly Competitive Salary
Job type:
PermanentDiscipline:
Statistics, Informatics, Programming**Location**:
Germany- Mainz (55131), Germany
- Posting date: 25 Mar 2024
Reference:
SS.HH.59624
**Associate Director Biostatistics - Permanent - Remote**
Proclinical are recruiting for an Associate Director Biostatistics to join a global biotech company. This role is on a permanent basis with the ability to work remotely from anywhere in the UK.
Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.
**Responsibilities**:
- Represent statistics in cross-functional project and study teams in multiple projects
- Provide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverables
- Perform sample size calculations, develop statistical analysis plans and lead TLF development
- Perform statistical analyses and validate analysis results
- Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
- Develop, implement and improve statistical processes and standards
- Support and participate in the development of departmental strategies
- Interact with global regulatory authorities
**Key Skills and Requirements**:
- PhD or Masters in statistics or biostatistics
- Five years (Master) and three years (PhD) experience in the pharmaceutical industry and/or CRO including submission experience
- Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
- Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking
- Preferred experience with clinical study designs in oncology or infectious diseases
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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