The Senior Biostatistician is responsible for producing and coordinating the production of analysis plans, statistical output, and study reports for clinical trial programs, as well as the evaluation of study protocols. The Senior Biostatistician also ensures all work is processed on time to appropriate quality levels and provide broad statistical support to non-biostatisticians within the company.Works independently on all level complexity clinical trial projects, often with major regulatory impact. The responsibilities will include producing and coordinating the production of analysis plans, statistical output, and study reports for clinical trial programs, as well as the evaluation of study protocols.
- Consulting with clients on clinical trial design, clinical trial program design, statistical / regulatory issues adding value by proactively suggesting approved ways of working.
- Ensuring all work is processed on time to appropriate quality levels and within budget.
- Understanding the regulatory requirements related to specific therapeutic areas and the implications for the statistical processing and analysis.
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
- Providing broad statistical support, including trial design, protocol, and case report form development on specific studies.
- Providing technical advice and support to non-biostatisticians within the company.Undertake the full range of duties relevant to the leadership, management, and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner.
- Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
- Other duties as assigned.
Minimum Work Experience
- Preferably employed as a biostatistician in the pharmaceutical industry / CRO for 3 years or 5+ years general experience as a senior biostatistician
Advantageous Experience
- Working knowledge of Clinical Data Interchange Standards Consortium (CDISC).
Education
- A 3 year degree or equivalent, in a statistical discipline is mandatory; a post graduate
Language Skills
- Fluent in English (speak, read, write).