Penfield Search Partners
Our client is a global pharmaceutical company with a diverse and well-developed pipeline that spans several therapeutic areas. They are seeking a Director of Biostatistics to play a key role in the development of Nephrology compounds. This is a visible, hands-on role that is also strategic – your input will be very important in effectively and efficiently developing processes for approval of these drug products. There will be a heavy focus on protocol development and on creative ways to look at data, and you will be encouraged to take a leadership role within your dedicated programs.
The Director of Biostatistics will oversee statistical work in early and late development phases for multiple compounds. You will be a necessary member of core project teams. In collaboration with cross functional team members, you will be responsible for Biostatistics for development of the compound(s), including efficient and effective trial design, analysis planning, modeling and simulation, submission reporting, advisory committee preparation and participation. You will ensure scientific rigor when applying statistical methods in clinical trials and will manage biostatisticians and mentor their career development.
Job Description
- Collaborate with other functions, such as clinical, clinical pharmacology, clinical operations and regulatory.
- Responsible for ensuring scientific rigor when applying statistical methods in clinical trials.
- Provide statistical expertise/input in the clinical development plan.
- Provide technical guidance to statisticians to ensure quality deliverables.
- Provide statistical support for development of protocols, SAP, CSR, summary documents, and briefing book for various regulatory interactions.
- Support regulatory interactions and participate in regulatory meetings and addresses statistical questions Participate in company-wide or functional projects, such as related to process improvements.
- Work with senior leaders and maintains close communication with partners both within and outside of the function.
- Engage with external statistical community and have awareness of new statistical methodology and regulatory guidance.
Qualifications
- PhD or M.S. in Statistics or Biostatistics.
- Minimum of 10 (or 12 for M.S.) years of experience in the pharmaceutical or related industry.
- Experience in early phase development preferred.
- Management experience preferred
Knowledge/Experience and Skills
- Strong knowledge of clinical trial development and regulatory guidance.
- Strong working knowledge of regulatory submissions for NDA and sNDA • Demonstrate ability to work in a team environment.
- Demonstrate ability to oversee junior statisticians.
- In-depth knowledge of statistical principles and applications.
- Strong computer skills such as SAS, R and other statistical software.