Company: Innovative Biotechnology Company
Job Title: Head of Biometrics
Location: California, USA
Salary: $220,000 - $330,00 plus an attractive bonus and benefits structure
Company Summary:
Our client is an innovative Biotechnology company dedicated to the development of antibodies in advance cancers. With funding from multiple investors, for their extensive pipeline, the company offer a stable career and development plan.
As the first hire for their Biometrics team, you will be responsible for the growth of the team, including, Statisticians, Programmers and Clinical Data Management. Reporting directly to the CMO, you will be part of the board of directors, discussing and making strategic decisions for the company.
Responsibilities:
- Lead the Biometrics function for the company, including, recruiting, developing the team of biostatistics, data management and statistical programming
- Providing strategic statistical input related to program and portfolio decisions
- Pivotal role in driving statistical strategy of clinical development providing statistical input to drug development planning
- Responsible for establishing FIH trial designs, and ensuring appropriate statistical parameters are in place
- Provides strategic statistical and regulatory guidance to anticipate challenges, risk and ensure project success
- Train new biostatisticians and programmers as necessary
- Draft, review and provide guidance for statistical sections of protocols, statistical analysis plans and for soundness of trial design
- Lead, Support and Oversee execution of Clinical Development Activities
Qualifications
- PhD in Statistics, Biostatistics or related field of study
- Minimum of 15+ years; of experience in the Pharmaceutical or Biotechnology industry
- Proven track record of growing teams in a small company environment
- 7 years' minimum experience of management experience leading Biostatistics and programming supporting clinical trials
- Extensive knowledge of Oncology across Phase I - IV studies
- Strong understanding of regulatory requirements and experience with regulatory interactions
