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Statistical Programming, Therapeutic Area Standards and Leader
4 months ago
at ClinChoice (View all jobs)
United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....
ClinChoice is searching for a Statistical Programming, TA Standards and Leader -Oncology to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
You will be working in the Oncology Biometrics Programming department reporting to a Sr. Director, Statistical Programming, providing leadership and management of standards governance activities at the therapeutic and study level related to the planning, execution and delivery of the data and the analysis reporting of clinical development.
This role will play a critical part in ensuring that the standards and the governance process are fit for purpose as these will form a key enabler for efficiency and automation initiatives.
The scope of work includes, but is not limited to, the governance of clinical data standards change requests, development of new Oncology TA standards, and participation in cross-TA standards development activities.
To succeed in this global role, you need to be an enthusiastic individual with an understanding of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You should enjoy multitasking and collaborating with others and have experience with solving problems and resolving conflicts.
Education and Experience:
Bachelor’s or Master’s (or local equivalent) degree in Mathematics, Statistics, Computer Science, Life or Social Sciences or related field Support the Oncology Therapeutic Area Standards Definition Team by reviewing change requests from oncology study teams for standard components (with focus on SDTM, ADaM, TLF) to ensure compliance with the CLIENT & CDISC standards, regulatory guidelines and Client Clinical data standards SOP, Protocol/SAP Support study teams with questions related to oncology standards (with focus on SDTM, ADaM, TLF) Participate in and contribute to working groups (including SME’s) during review and optimization of existing Corporate and Oncology Standards Participate and contribute in working groups (including SME’s) during development of new Oncology standards (e.g. hematology and cell therapy) Standards development (e.g. SDTM/ADaM, TLF) in collaboration with SMEs to ensure alignment with key TA documents e.g. SAP Participate and contribute to the development of programming tools Corporate and Oncology) to facilitate automation. Standards improvement, end-to-end, collaborative, problem-solving mind-set. Strong communication, leadership and influencing skills.
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