Passion for Innovation. Compassion for Patients. With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
Position: Manager Statistical Programming (m / f / x)
The position: The position holder will manage, with direction, end-to-end delivery of Statistical Programming services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget. The position holder will partner with internal and external stakeholders to optimize Statistical Programming technology, processes, and standards. The position will have a working knowledge of Statistical Programming applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.
Roles & Responsibilities: Study level statistical activitiesResponsible, with supervision, for study activities assigned to Statistical Programming including but not exclusive to SAPs and TFL shells review from a programming perspective, contribute to develop specifications for SDTMs and ADaM datasetsContribute to develop and validate SAS programs to create SDTM and ADaM datasets and TFLs, demonstrate knowledge with XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMsEnsure timely and accurate completion of Statistical Programming deliverablesContribute, with supervision, to documents submitted to Regulatory or Pricing AuthoritiesMust comply with international regulations and maintain inspection readinessEnsure inspection readiness as well as prepare potential audits linked to assigned studiesVendor OversightWith supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelinesParticipates in drafting request for proposal for CRO selection. Reviews baseline budget and timelines
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