RESPONSIBILITIES AND ACCOUNTABILITIES
- Lead full scope of Biostatistics contributions to the responsible areas. Coordinate with internal and external stakeholders through the Stage Gate process.
- Partner with TA Head and other functional leads within the areas. Influence and contribute to clinical development plans (CDPs/TPPs). Ensure full integration of statistical strategy and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
- Ensure sound statistical foundation underpinning program strategy within the responsible area. Be accountable for the quality of statistical strategy and analysis planning for clinical trials and regulatory submissions.
- Represent Biostatistics in interactions with authorities, including FDA, EMA, PMDA, etc.
- Provide statistical leadership dealing with concepts and complexity comfortably. Interact effectively with senior management and external KOL.
- Coordinate priorities and monitor outsourcing operations within the responsible areas. Ensure timeliness and quality of deliverables by CRO.
- Manage the Biostatistics team to achieve corporate and department goals. Provide technical statistical expertise, leadership and serve as a role model and mentor to staff. Mentor staff and cultivate professional growth.
- Extend influence and leadership across functions. Identify and lead opportunities for infrastructure / process / scientific consulting improvement initiatives and related standards
Reports To: Head of Global Biostatistics and Statistical Programming
Direct Reports: Statisticians and/or statistical programmers
PhD or MS in Biostatistics, Statistics, or related fields
- 10 years of experience in Clinical Development in a Pharmaceutical or Biotechnology setting
- Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
- Significant experience in interactions with major regulatory authorities and regulatory submissions
- Experience managing people preferred
- Experience managing CRO preferred
- Track record of innovation desired
- Broad knowledge of statistical theories and applications of advanced statistical methodologies
- Broad knowledge of clinical development and processes
- Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management
- Ability to collaboratively work and provide leadership in matrix environment
- Strong problem solving skills
- Expertise in
- Statistical methodologies
- CDISC, statistical programming, and/or data standards
- Biostatistics and Statistical Programming Operations