Associate Director, Statistics

Takeda•Boston, MA

13d

About The Position

Takeda’s mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda’s R&D pipeline. Central to Takeda’s R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Global Evidence Outcomes, Patient Safety & Pharmacovigilance, and Strategic Operations The department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. 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, 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.

Requirements

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.
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
PHD with ~ 5 years experience
MS with ~ 8+ years experience

Responsibilities

Lead delivery for one or more assets at GPT level or specialty area in clinical
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
Asset-level GPT strategy and delivery
Broadly DQS functions
Parts R&D functions.
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