Associate Director, Statistical Programming
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Associate Director, Statistical ProgrammingApply Now
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.
- 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.
- 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:
- 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.
No Phone Calls or Recruiters Please.
Job ID R0023451