Director, Statistics-GI at Takeda in Boston, MA

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Job Description

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:

OBJECTIVES

• 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

ACCOUNTABILITIES:

• 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

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