Senior Principal (m/f/x) DX-DSS Data Engineering

Select how often (in days) to receive an alert:Senior Principal (m/f/x) DX-DSS Data EngineeringDate: 25 Sept 2025Passion for Innovation. Compassion for Patients.With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.Purpose of the functionThe position holder will manage, with very limited direction, end-to-end delivery of Data Engineering 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 Data Engineering technology, processes and standards.The position will have a strong knowledge of Data Engineering applications and industry standards and strong technical skills in working with data received from CROs and other third-party vendors.The position holder will require strong skills in continuous improvement, project management, change management and risk management.Roles and ResponsibilitiesFully responsible with very limited direction for small projects or for an Indication in a large project. Support project leadership by assisting with the coordination of deliverables performed by direct reports or line functions assigned to the project within global/regional evidence generation activities.Assist in maintaining project timelines and budget, working closely with partner line functions.Serve as a secondary escalation point for Data Engineering concerns related to statistical programming activities within assigned programs.Contribute to identifying and managing risks at the functional level and for assigned programs or initiatives.Project responsibilityResponsible, with very limited supervision, for study activities assigned to Data Engineering, including SAPs and TFL shells review from a programming perspective, developing SDTM and ADaM dataset specifications, and developing and validating SAS programs to create SDTM, ADaM datasets, and TFLs. Demonstrate knowledge with XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTMs and ADaMs.Identify innovative ways to improve the efficiency, quality, and productivity of clinical statistical programming and actively contribute to implementation.Contribute to maintaining awareness of industry standards, global regulatory requirements, internal guidelines, and Standard Operating Procedures (SOPs).Ensure timely and accurate completion of Statistical Programming deliverables.Contribute, with very limited supervision, to documents submitted to Regulatory or Pricing Authorities.Ensure compliance with internation regulations and maintain inspection readiness.Prepare and may participate in potential audits linked to assigned studies.Participate in meeting or teleconferences with Health Authorities.Responsible for providing direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Responsible for CRO selection from RFI to contract agreement including, review and negotiation of base-line budget and timelines.Oversees budget management activities across the study/ project duration.Operational excellence InnovationMay lead and / or participate in Data and Statistical Science initiatives to improve the harmonization and efficiency of process and/or develop and implement innovative solutions.Maintains current knowledge of industry best practice in Data Engineering methodology, Data Integrity and Data Privacy.May act as Subject Matter Expert for Data Engineering, by providing guidance and support to Data and Statistical Science team members as well as represent EG department in cross-functional teams.Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards.Demonstrates leadership within Data Engineering by partnering with internal and external stakeholders to optimize Data Engineering technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).Line ManagementAdministrative responsibilities for recruiting, retaining, coaching, developing, and managing individual contributors.May lead a small team (andlt; 5 people).May lead a cross functional project team.Professional Experience and EducationBSc or MSc (preferred) in Statistics, Computer Science or related fields.At least 8 years experience CRO, Medical Device Company and at least 2 in Pharma.Experience in oncology Therapeutic Area and/or in late phase projects is an advantage.Skills and Additional RequirementsExcellent communication skills, both oral and written, in explaining in simple terms complex concepts.Proficient negotiation and project management skills.Demonstrates entrepreneurship and leadership and proactive problem solving.Proven data pooling expertise is recommended.Extended knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.Ability to work remotely with worldwide team members across cultures and time zones.Solid understanding of GCP and GDPR principles.Advanced working knowledge all SAS language, procedures and options commonly used in clinical trial reporting including theMacro language, BASE SAS, SAS/STAT and SAS/GRAPH. Knowledge of SAS Enterprise Guide and/or SAS Studio is recommended.Previous experience supporting SAS macro and/or system utility development is highly preferred.Solid knowledge of new advanced statistical methods using SAS.R knowledge is highly recommended but not required.Solid understanding of GCP and GDPR principles.Why 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. #J-18808-Ljbffr