Associate Director, Biostatistics

Responsibilities:
- Represent biostatistics in cross-functional meetings to drive clinical development and provide input on clinical development plans.
- Collaborate with Clinical Development, Regulatory, and Clinical Operations to design clinical trials.
- Write statistical sections of clinical trial protocols (with internal/external expert input).
- Contribute to or prepare statistical analysis plans; provide statistical guidance for ongoing trials.
- Collaborate on eCRF design; work with Statistical Programmers on trial data summary/analysis.
- Write ADS and ad hoc analysis specifications.
- Contribute to clinical study reports and regulatory documents (e.g., DSURs, Briefing Documents).
- Represent the company in meetings with regulators, KOLs, partners, and other stakeholders.
- Contribute to scientific articles; participate in other biostatistics/development activities as needed.
- Consult with research/preclinical colleagues on statistical questions.
- Manage CRO statistical/programming support.

Qualifications:
- Ph.D. in Biostatistics/Statistics (or equivalent) with 7+ years pharmaceutical biostatistics experience, or MS with 10+ years relevant experience.
- Excellent written/oral communication and presentation skills.
- SAS programming experience.
- Basic understanding of biology/biological processes, including RNAi.

Desired experience/skills:
- Phase 3 clinical development experience (NDA submission).
- Lead statistician experience; knowledge of ICH GCP and industry standards.
- Proficiency in R and other statistical software (including EAST).
- CDISC experience (SDTM, ADaM, CDASH).
- Experience representing sponsors with US FDA and international authorities.
- Experience designing and conducting adaptive trials.

U.S. Pay Range: $185,300.00–$250,700.00; eligible for annual short-term and long-term incentive awards.