- Support all aligned TA development projects and marketed products and maximize statistical contributions to clinical, regulatory, and commercial development strategies
- Promote efficient innovative designs and optimal development plan
- Contribute to strategies for statistics related technologies, processes, and standards
- Provide insight and continual research into future direction of statistics
- Lead development of short and long-range strategies and goals for the aligned TA statistics group with multiple sub-TAs
- Partner with aligned functional TA heads to maximize statistical contributions to clinical, regulatory, and commercial development strategies
- Ensure adequate statistical support for all aligned TA development projects and timely delivery of statistical deliverables
- Oversee aligned TA statistics resource needs
- Develop and retain statistical talents in the group
- Ensure productive collaborations with other functions in the aligned TA development organization and with other statistics TA heads
- Promote innovative designs and efficient analysis methodologies in clinical trials
- Provide statistical advice and consultation to aligned TA development management
- Keep the group current on statistical methodologies relating to drug development and regulatory requirements
- Build and maintain a good network with statistical experts
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- PhD or MS in Statistics or Biostatistics
- 12+ years of pharmaceutical/biotech experiences with a PhD degree and 15+ years with an MS degree
- Excellent technical skills
- Good knowledge of statistical methodologies for aligned TA clinical trials
- Outstanding communication skills
- Strong leadership and influencing skills
- Interact effectively with regulatory authorities
- NDA/BLA filing experience
- Ability to influence others, at all levels of the organization, without direct hierarchical authority, and affect change across organizational boundaries.
- Ability to collaborate effectively with peers, within global teams and in communicating with senior leadership.
- Must be a strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way.
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