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 an Associate Director, Statistics in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the Global Statistics team, you will be empowered to innovate design and build strategies. A typical day will include:
Serves as global statistical expert for major development programs, leading and managing a team of statisticians
Oversees all statistics activities for one major clinical program or multiple clinical programs to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions.
Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up.
Establishes and drives therapeutic area(s) program functional strategy for resourcing, processes and standards to maximize efficiency and global data integratability.
Participates in functional and cross functional initiatives including process and quality improvements
Serve as global statistical lead for assigned therapeutic areas or phase of development or CMC/non-clinical activities.
Lead and manage team of statisticians supporting cross region studies and programs for identified therapeutic area(s) or phase of development or CMC/non-clinical activities; manages assignments and priorities of team members.
Develop and mentor staff by utilizing appropriate internal and external resources to achieve short term and long term strategic functional goals.
Promote innovative clinical trial designs and efficient analysis methodologies
Play a leadership role in development and completion of major statistics deliverables and milestones in collaboration with other functions.
Drive/participate in development and implementation of global systems, processes and standards to maximize quality and efficiency.
Leverage standardized analysis methods and reporting standards to maximize global data integratability; identifies best practice for utilization across programs.
Provide statistical leadership and support for regulatory meetings, submissions and follow up.
Provide or identify internal and external statistical expertise and capacity to support development activities.
Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality.
Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level.
Provide input for planning and management of external budgets related to statistical deliverables.
Participate/Leads in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practice and its applicability in Takeda.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
PhD in statistics or biostatistics with at least 7 years of relevant pharmaceutical industry experience or MS 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.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.