Associate Director, Statistics, Rare Genetic Hematology at Millennium Pharmaceuticals, Inc. in Boston, Massachusetts

Job Description:

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Job Description

Objective

• Serves as global statistical expert for major development programs, with potential for 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,

Accountabilities

• 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.

Requirements

• PhD in statistics or biostatistics with at least 8 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

Locations

Worker Type

Worker Sub-Type

Time Type

Full time