Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, Statistics in our GI group in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director-Statistics ( working on the team, you will be empowered to p rovide statistical leadership in the design, analysis, and interpretation of clinical studies at a compound level for the GI Therapeutic Area Unit (TAU), promoting innovative design and analysis methodology , and a typical day will include:
- Lead and manage a team of statisticians in a subgroup within the GI Therapeutic Area Unit (TAU). Support all GI development projects assigned to his or her team and maximize statistical contributions to clinical, regulatory, and commercial development strategies
- Independently provides strategic and expert statistical input to neuroscience drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up.
- Promote efficient innovative designs and optimal development plan
- Contribute to strategies for statistics related technologies, processes, and standards
• Ensure adequate statistical support for GI development projects in the group and timely delivery of statistical deliverables
• Oversee aligned statistics resource needs
• Develop and retain statistical talent in the group
• Ensure productive collaborations with other functions and other groups
• Promote innovative designs and efficient analysis methodologies in clinical trials
• Provide statistical advice and consultation to development teams
• Keep the group current on statistical methodologies relating to drug development and regulatory requirements
• Build and maintain a good network with external statistical experts
Required EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:
- PhD in Statistics or Biostatistics and 10+ years of pharmaceutical/biotech experiences with a PhD degree
- PhD in statistics or biostatistics with at least 10 years of relevant pharmaceutical industry experience
- Experience with at least two NDA/CTDs or other regulatory submissions.
- Experience representing Statistics function in interactions with regulatory agencies.
- Advanced knowledge of clinical study designs, analysis methodology and data interpretation.
- Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
- Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
- Strong statistical programming skills
- Excellent oral and written communications skills.
- Specialized statistical expertise in multiple therapeutic areas or development phases.
- Strong inter-personal and people management skills.
- Strong project management skills.
- Strong collaborative skills and ability to work with a cross-functional team.
- Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries.
- Ability to inspire and motivate staff