Senior Manager- Statistics

Takeda; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading biopharmaceutical company is seeking a skilled professional to lead clinical delivery at the GPT level. The ideal candidate will have advanced statistical knowledge, strong leadership skills, and a PhD with approximately 5 years of experience in related fields. Key responsibilities include facilitating collaboration within Global Project Teams and identifying opportunities for improvement in delivery approaches. This role includes contributing to innovative treatments and improving operational excellence in drug development.

Qualifications

• Advanced knowledge of pharmaceutical industry and drug development process.
• Expertise in FDA and ICH regulations applicable to clinical trials.
• Specialized statistical expertise in multiple therapeutic areas.

Responsibilities

• Lead delivery for one or more assets at GPT level in clinical.
• Facilitate execution and delivery collaboration cross functionally in Global Project Teams.
• Identify opportunities for continuous improvement in delivery approaches.

Skills

Advanced knowledge of clinical study designs

Strong statistical programming skills

Excellent oral and written communications skills

Strong collaborative skills

Education

PHD with ~ 5 years' experience

Job description

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 committed to 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, 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:

• 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

Contributions:

• Asset-level GPT strategy and delivery
• Broadly DQS 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 collaborative skills and ability to work with a cross-functional team.

Technical/Functional (Line) Expertise:

• 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:

• 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:

• PHD with ~ 5 years' experience
• Inspire teamwork
• Assess benefit risk of options
• Develop understanding of business beyond SQS