Expert Statistical Programming (m/f/x)

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 EU regional headquarters (position can also be based in an EU affiliate) we are seeking highly qualified candidates to fill the position:

Expert Statistical Programming (m/f/x)

The Position:

The position holder will support end-to-end delivery of Statistical Programming services for assignedstudies, collaborating with CROs and other vendors to ensure high quality deliverables are ontime and within budget.The position holder will support study lead and partner with internal and external stakeholders tooptimize Statistical Programming technology, processes, and standards.The position will have a working knowledge of Statistical Programming applications and industrystandards, and fundamental technical skills in working with data received from CROs and other thirdpartyvendors.

Roles and Responsibilities:

• Study level statistical activities: Responsible, with supervision, for operational aspects of study activities assigned to Statistical ProgrammingIncluding but not exclusive to SAPs and TFL shells review from a programming perspective,Limited contribution to develop SDTMs and ADaM datasets specifications, contribute to developSAS programs to create SDTM and ADaM datasets and TFLs based upon provided specsEnsure timely and accurate completion of Statistical Programming deliverablesMust comply with international regulations and maintain inspection readinessEnsure inspection readiness as well as prepare potential audits linked to assigned studies

• Vendor Oversight: With supervision, responsible for routine oversight of vendor delivery, to ensure compliance withthe protocol, external/internal standards applicable regulatory guidelines, policies, SOPs, and otherrelevant guidelines.Participates in drafting request for proposal for CRO selection.Reviews base-line budget and timelines.Contributes to budget management and activities across the project duration

• Operational Excellence Innovation: Participate 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 methodology

• Any other duties deemed pertinent to the needs of the business.

Personal Skills and Professional Experience:

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.

• Excellent English language skills High

• Understanding of GCP and GDPR principles Medium

• Good communication skills, both oral and written, in explaining in simple terms complex concepts Medium

• Knowledge of SAS language, procedures and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Medium

• Baseline knowledge of advanced statistical methods using SAS Low

• Baseline knowledge of advanced statistical methods using SAS Low

• Knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research. Medium

• Ability and interest to work remotely with worldwide team members across cultures and time zones Medium

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