Manager Statistical Programming
hace 2 semanas
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.For our European Headquarter in Munich or other affiliates in Europe we are looking for aManager Statistical Programming (m / f / x)The position :The position holder will manage, with direction, end-to-end delivery of Statistical Programming ser-vices 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 Pro-gramming 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.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 datasets, contribute 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 studiesWith supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external / internal standards applicable regulatory guidelines, Policies, SOPs, and other rele-vant guidelinesParticipates in drafting request for proposal for CRO selection. Reviews base-line budget and time-lines. Contributes to budget management and activities across the project durationOperational Excellence InnovationParticipate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and / or develop and implement innovative solutionsMaintains current knowledge of industry best practice in Statistical Programming methodologyAny other duties deemed pertinent to the needs of the business.Professional experience & education :Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required; master’s degree in bio / statistics preferredAt least 2 years of experience supporting drug development and / or post marketing in clinical re-search, Pharmaceutical, CRO or Medical Device settingExperience in oncology Therapeutic Area and / or in late phase projects is an advantageCompetencies and Generic SkillsGood understanding of GCP and GDPR principlesGood communication skills, both oral and written, in explaining in simple terms complex conceptsAdvanced working knowledge all SAS language, procedures and options commonly used in clinical tri-al reporting including the Macro language, BASE SAS, SAS / STAT and SAS / GRAPH.Knowledge of SAS Enterprise Guide and / or SAS Studio is recommended but not requiredPrevious experience supporting SAS macro and / or system utility development is preferredSolid knowledge of new advanced statistical methods using SASR knowledge is highly recommended but not requiredThorough knowledge and understanding of the principles, concepts, methods, and standards of Clini-cal Research.Fundamental negotiation and project management skillsAbility and interest to work remotely with worldwide team members across cultures and time zonesWhy work with us?Working at Daiichi Sankyo is more than just a job it is your chance to make a difference and change patients’ lives for the better.We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity.Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
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