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TakedaPharmaceutical Nordics AB · 21 hours ago

Sr. Director, Statistics

Boston, MA

Full-time

Onsite

Director/Executive

$208K/yr - $327K/yr

12+ years exp

TakedaPharmaceutical Nordics AB is committed to serving patients through innovative medicines and improvements in healthcare. They are seeking a Senior Director in Statistics to lead the execution and delivery of strategic missions in R&D, focusing on optimizing business impact through data science and quantitative methods.

Pharmaceuticals

Responsibilities

Play key role in execution and delivery leadership of Therapeutic Area Unit (TAU), Business Unit (BU), or SQS function or specialty area in preclinical / clinical / translational

Be the cross functional leader and accountable execution and delivery decision maker that has direct impact on R&D

Define and contribute to execution and delivery strategic mission and the respective implementation for the promotion of R&D seamless and predictable delivery

Proactively identify risks and mitigation strategies to optimize R&D business impact in terms of costs, quality, and timeliness

Be accountable for growth and development of SQS delivery capabilities through processes, systems and oversight mechanisms

Show influential execution and delivery leadership both within and outside of Takeda with vendors and partners

Provide strategic vision for long-term delivery innovation

Qualification

PhD in scientific disciplineNDA/CTDs experienceClinical study designStatistical programmingFDAICH regulationsPharmaceutical industry knowledgeOral communication skillsWritten communication skillsInterpersonal skillsProject management skillsCollaborative skillsMotivational skills

Required

PhD degree in a scientific discipline with 12+ years' experience, or MS with 15+ years' experience

Experience with at least one 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 interpersonal and people management skills

Strong project management skills

Strong collaborative skills and ability to work with a cross-functional team

Ability to inspire and motivate staff