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Associate Director, Statistical Programming

Boston, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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Associate Director, Statistical Programming

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Job ID R0023451 Date posted 09/30/2020 Location Boston, Massachusetts

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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.  Join us as a Associate Director, Programming Innovations

in our Cambridge office.

OBJECTIVES: 

  • Support the development and implementation of the global functional strategy related to innovation in technologies and automation, processes and standards to maximize efficiency and quality.
  • Support the development and implementation of a global programming ecosystem for enabling successful outsourcing partnerships in quality and timeliness for delivery while ensuring that the technological needs of the Statistical and Quantitative Sciences department are met.
  • Participate in the development and implementation of an end-to-end data standards strategy that enables innovation, automation, reusability, and interoperability.
  • Educate the SQS department on the latest regulations and standards requirements relative to electronic data submissions.
  • Collaborate with the TA Leads on specific projects that support department strategies around efficiency and reusability
  • Support the Data Sciences Institute in evaluating novel approaches to real world data, artificial intelligence, and machine learning, and new initiatives relating to data classification, governance and sharing.

ACCOUNTABILITIES: 

  • Actively engage with R&D IT to ensure that the statistical computing environment meets requirements of a Part 11 validated system as well as Takeda R&D needs relative to data access and controls.
  • Support the development of department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables. 
  • Identify gaps in oversight and management of CRO/vendor partners and lead key initiatives that challenge the status quo and lead to measurable performance improvements.
  • Develop innovative solutions in the programming space to standardize, automate and reduce manual labor to arrive at optimized R&D quality, costs and timeliness.
  • Develop tools and utilities that enable efficient quality control and verification of derived datasets, e.g. SDTM and ADaM, and outputs.
  • Develop tools and utilities that enable efficient production of in-house deliverables.
  • Partner with the entire SQS organization, inclusive of Safety Statistics, to provide access to internal and external programming and software expertise.
  • Support development of and training on relevant Takeda SOPs, job aides and work instructions to guide department standard practice.
  • Use technical expertise in SAS, R, Python and other software packages to support DSI data cataloguing, anonymization and sharing activities
  • Leverage technical expertise in ML/AI and other digital technologies to support DSI initiatives and strategy related to real time review of trial data and its integration with real world data

EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:

Required

  • BS or MS in Statistics, Biostatistics, Computer Science, or related analytical field
  • 12 + years (MS) or 14 + years (BS) SAS programming experience in the pharmaceutical/CRO industry with support of clinical trials across all phases of development including NDA/AMA/CTD submissions
  • 6+ years of CRO/Vendor management experiences
  • In-depth knowledge of statistical programming languages (including SAS), software, techniques, and products related to statistical programming, databases and computing environments.  Strong knowledge of SAS software products related to the pharmaceutical industry, and common software products and technologies used in conjunction with SAS (e.g., Microsoft OfficeÒ)
  • Solid understanding of FDA, EMA, ICH and other regional and global regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions, eg. CDISC standards
  • Expertise in the requirements and technology required to support electronic submissions.
  • Technical expertise with UNIX/LINUX operating systems
  • Strong leadership skills, including strategy development  
  • Strong project management skills
  • Excellent oral and written communications skills

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

Empowering Our People to Shine

Learn more at takedajobs.com.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023451

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