Associate Director, Statistics

Key Skills

Unix Operating system, Microsoft Office suites, Statistics, SAS

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.

Here, teamwork is everything. Drug discovery, design and development is increasingly more complex and every individual on the team matters to the success of our inspiring, bold mission. You are guaranteed to be a vital contributor to everyone’s success, most importantly your own. As an Associate Director, Statistics, you will be empowered, and will have the opportunity to serve as scientific leader who will provide statistical leadership in the design, analysis, and interpretation of clinical and translational studies at both the compound and therapeutic area (TA) levels, promoting innovative designs and methodologies.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

• Drives all statistical aspects of biomarker development for Takeda R&D assets for Oncology Cell Therapy and TA covering design and analysis from pre-clinical to early clinical studies.
• Drives data driven decision making in multidisciplinary team environment (comprising of preclinical, biomarker, translational and clinical scientists, and computational biologists and quantitative pharmacologists) by providing high level of statistical rigor to the analyses and interpretation of complex data generated by translational teams
• 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 Oncology Cell Therapy and TA programs functional strategy for resourcing, processes and standards to maximize efficiency and global data integrability.
• Participates in functional and cross functional initiatives including process and quality improvements.

POSITION ACCOUNTABILITIES:

• Serve as global statistical lead for biomarker development in Oncology Cell Therapy and TA. Provide statistical leadership and support for internal decision making, regulatory meetings, submissions and follow up.
• Review key program documents and presentations (portfolio entry document, PRC narratives, biomarker strategy plan), attend Translational Research meetings to develop a comprehensive overview of the existing data in pre-clinical and translational studies, form a deep understanding of the development rationale and strategy and the key questions that need to be answered from biomarker data, and help the teams identify any statistical shortfalls and propose solutions to overcome them
• Attend scientific conferences (AACR, ASCO, SITC) and stay abreast with the latest developments in IO and cell therapy space with an eye towards acquiring biomarker data that can help augment internal data
• Play a leadership role in development of Exploratory Analysis Plans and completion of major statistics deliverables and milestones in collaboration with other functions
• Stay up-to-date on emerging technologies and associated data analytic techniques, external databases and novel methodologies that can help Takeda derive the maximum value out of the biomarker data
• 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 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.
• Active participation in external professional initiatives and organizations to identify industry best practice and its applicability in Takeda.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• PhD in statistics/biostatistics or in bioinformatics with an emphasis on statistics with at least 6 years of relevant industry experience or MS in statistics with at least 10 years of relevant industry experience
• Team work is key for this role. Candidate will be expected to routinely interface with other quantitative functions in industry and must have strong inter-personal and people management skills, and ability to influence others, without direct hierarchical authority, to affect change across organizational boundaries.
• Expert knowledge across broad areas of statistical methodologies inlcuding subgroup analysis, longitudinal data analysis, multivariate methods, predictive modeling, machine learning, Bayesian modeling. Strong background in statistical modeling in R or SAS with the ability to independently code relevant programs.
• Expert knowledge of statistical approaches for assays, and biomarker development and validation.
• Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
• Excellent oral and written communications skills.
• Strong project management skills.
• Knowledge of IO Biology and experience working with raw data from emerging biomarker technology platforms in the space (CyToF, TCRSeq, Multiplexed IHC) is a plus

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement 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

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.