This an exciting time to join a rapidly growing and dynamic Arena, with a robust portfolio of assets across multiple therapeutic areas. We are in search of a leader that will have the vision and experience to grow the internal biostatistics and data management team and engage with strategic partners to ensure Arena is positioned for success.
The Head of Biostatistics and Data Management will have overall responsibility and accountability of Biostatistics, Statistical Programming and Clinical Data Management (CDM) across the portfolio as it relates to all stages of development including the clinical related components of regulatory submissions, and in the future may include post-marketing activities.
What you’ll dive into:
- Provide statistical support of strategic planning, authoring, and review of manuscripts and other scientific data disclosures
- Review clinical study protocols, providing statistical feedback and input on project design issues, endpoint definition and sample sizes; provide sample size calculation and documentation
- Write and/or review Statistical Analysis Plans including Mock tables, listings and figures; ensure programming specifications are met
- Define and drive preparation of statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Briefing Books, NDA/CTD, Regulatory Responses).
- Provide strategic direction for all data management and statistical programming systems and software, capabilities and standards
- Responsible for cross functional standardization, technology, process improvement and resource forecasting
- Perform programming validation and ensures all Quality Control efforts have been followed
- Oversight of build, validation, and maintenance of clinical trialdatabases in accordance with ICH/GCP guidelines and current regulatory requirements.
- Manage internal team and resources, including external consultants, CROs and regulatory agencies
- Facilitate and ensure effective communication between CDM team and cross-functional areas
What we expect:
- PhD in Statistics, Mathematics, preferred
- 12+ years of industry experience from pre-clinical through commercialization
- 8+ years managing Biostatistics, Statistical Programming and Clinical Data Management at both a tactical and strategic level
- eCTD NDA submission experience
- Advanced proficiency in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS and other relevant statistical software (eg. R)
- Extensive knowledge of GCP, ICH guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines
- Advanced understanding of all programming tasks, troubleshooting problems and identifying data trends
- Ability to lead a high-functioning team managing multiple programs with competing timelines, in addition to providing mentorship and personnel development
- Demonstrated problem solving skills, ownership and project management skills
- Ability to travel, and in some cases, internationally
What you’ll get
- To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
- Opportunities to learn and contribute creative solutions
- Comprehensive health insurance ($0 premium on select medical plans)
- Matching 401k retirement plan
- Paid time off and holidays including a Summer & Winter break
- Company celebrations.