Associate Director, Biostatistics

Responsibilities:
- Support clinical development teams with statistical elements of study design, analysis, and decision-making; advise on methodologies; perform modeling and simulations; leverage external experts as needed
- Contribute to the development and evaluation of technical infrastructure to facilitate efficient clinical trial execution and evaluation
- Select, implement, and execute statistical methodologies and related processes
- Review key project and study documents for optimal statistical presentation and compliance
- Facilitate and oversee creation of standards for key variables, definitions, statistical methods, data structures, and presentation of data
- Prepare statistical aspects for meetings with regulatory authorities, key opinion leaders, and similar experts
- Support Clinical teams’ interactions with clinical investigators to determine protocol design
- Evaluate databases and statistical analysis programs to determine optimal technical solutions
- Stay current on new statistical methodologies and regulatory guideline updates; signal relevant developments to project teams

Qualifications:
- Master’s Degree in Biostatistics required; PhD preferred
- 5+ years applying statistical methods in biomedical research
- 3+ years pharmaceutical and/or CRO experience required
- 3+ years ADaM experience required
- Experience with all stages of clinical development, especially late stage strongly preferred
- Advanced/broad knowledge of statistical methods and industry practices for clinical data analysis
- Advanced knowledge of statistical methods applicable to clinical development
- Experience with statistical and data requirements for health authorities (e.g., FDA); experience with European regulatory bodies and PMDA is a plus
- Experience in all aspects of statistics for clinical trials and in project-team design of clinical studies
- Strong understanding of functions/expert groups contributing to drug development
- Strong SAS programming skills; R proficiency is a plus

Benefits:
- Medical, Vision and Dental benefits (first of the month following start date)
- Generous paid time off and company designated holidays
- Company paid disability benefits and life insurance
- 401(k) Retirement Savings Plan
- Paid parental leave
- Employee Stock Purchase Plan (ESPP)
- Company sponsored wellness programs
- Professional development initiatives and continuous learning opportunities

Physical demands/work environment:
- Domestic travel up to 5%
- Ability to occasionally lift/move over 20 pounds
- Continuous sitting; close vision; manual dexterity to use computers/tablets/cell phone