ASSOCIATE DIRECTOR, STATISTICS

Job Description About the role.
The Biostatistics, Associate Director is responsible for providing statistical support for development projects in the GI2 Therapeutic Area statistics group and timely delivery of statistical deliverables.
This role contributes to Takeda's mission.
How you will contribute.
Design and lead clinical trials, providing strategic oversight and innovative solutions Conduct advanced statistical analysis and ensure robust and accurate data analysis through extensive knowledge in biostatistics Facilitate execution and delivery collaboration with cross-functional teams to achieve project objectives Drive the adoption of new statistical methods and technologies Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Skills and qualifications.
Advanced knowledge of clinical study designs, analysis methodology and data interpretation.
Advanced knowledge of drug development 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.
Skilled in leadership, able to guide and develop a team of statisticians and programmers.
Strong collaborator, working effectively with cross-functional teams to achieve project objectives.
Innovative thinker, driving the adoption of new statistical methods and technologies.
Strategic planner, adept at developing comprehensive statistical components for complex research projects.
Strong statistical programming skills Excellent oral and written communications skills.
Specialized statistical expertise in multiple therapeutic areas or development phases.
(Experience in GI and/or immunology preferred.) Strong inter-personal and people management skills.
Strong project management skills.
Strong collaborative skills and ability to work with a cross-functional team.
As a recognized expert within your business or function, you possess comprehensive expertise in your discipline and broad knowledge across related areas.
You excel at anticipating internal/external challenges, recommending improvements, and providing leadership and consultative expertise for a specific business, region or function.
Your role involves shaping company policies, solving unique, far-reaching problems affecting operations, disciplines, or other business units/functional areas/regions.
You frequently interact with equivalent-level managers and customer representatives, conducting briefings and technical meetings.
Operating independently, you provide guidance in the most complex situations, lead functional teams or projects, and serve as a best practice/quality resource.
OBJECTIVES/PURPOSE.
Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
Our Data and Quantitative Sciences (DQS) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients.
These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines.
They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.
As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators.
SQS aspires to bring safe and effective medications to the patients with our quantitative skills.
We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence.
Delivery & Business Accountabilities.
An Associate Director in Statistics / Data Science / Quantitative Science is expected to.
Lead delivery for one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them The Associate Director in Statistics / Data Science / Quantitative Science, through her/his daily work, should have impact on.
Asset-level GPT strategy and delivery Broadly DSI functions Parts R&D functions.
CORE ELEMENTS RELATED TO THIS ROLE.
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.
​ CORE ELEMENTS RELATED TO THIS ROLE.
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.
Serve as global statistical lead for biomarker development in Oncology TA.
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 integrability; identifies best practice for utilization across programs.
Provide statistical leadership and support for internal decision making, 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 Technical/Functional (Line) Expertise.
The associate Director in Statistics / Data Science / Quantitative Science needs to demonstrate.
Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics Scientific understanding of drug R&D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs that he/she is involved in Leadership.
As a Statistician / Data Scientist / Quantitative Scientist, the Associate Director may have to.
Lead one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Create an internal and external sphere of influence in area of expertise EDUCATION.
Applicant for this position should have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials.
PHD with ~ 5 years experience MS with ~ 8+ years experience BEHAVIOURAL COMPETENCIES.
An ideal candidate for this position should.
Inspire teamwork Assess benefit risk of options Develop understanding of business beyond SQS Focuses on priorities Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career.
We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location.
Boston, MA U.
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Base Salary Range.
The estimated salary range reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.
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based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s.
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based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
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based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.