Penfield Search Partners
Our client is a leader in the translation of RNAi into a new class of innovative medicines with applications across several therapeutic areas including Rare Disease, Cardio-Metabolic, Infectious and CNS. They are currently seeking an Associate Director of Biostatistics to provide statistical leadership and strategic input into their largest program in the Rare Disease area. The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.
You will:
- Represent Biostatistics at cross-functional team meetings to drive clinical development of drug candidates and to provide input on clinical development plans
- Collaborate with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials
- Write the statistical sections of clinical trial protocols, while consulting with internal and external experts
- Contribute to or prepare statistical analysis plans
- Collaborate with Data Management, Clinical Development and Clinical Operations on design of eCRFs
- Provide statistical guidance on conduct of ongoing trials
- Collaborate with Statistical Programmers on summary and analysis of trial data
- Writes ADS and ad hoc analysis specifications
- Contribute to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
- Represent in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders
- Contribute to scientific articles, summarizing data collected in trials
- Participate in other activities and meetings to support Biostatistics and the Development Team as needed
- Consult with Research & Preclinical colleagues on statistical questions in their work
- Manage CRO statistical and programming support.
Qualifications
- PhD. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience
- Excellent written and oral communication and presentation skills
- Experience programming in SAS
- Interest in and basic understanding of biology and biological processes, including RNAi
Desired Experience:
- Experience in clinical development through Phase 3 (NDA submission)
- Experience as lead statistician for a compound
- Understanding of ICH GCP as well as general knowledge of industry practices and standards
- Proficiency in R programming language and other statistical software, including EAST
- Experience with CDISC, including SDTM, ADaM, CDASH
- Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities
- Experience designing and conducting adaptive trials