Passion 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.
The position holder will manage, with supervision, 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 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 AND RESPONSIBILITIES
Project responsibility
Responsible, with supervision, for handling assigned operational tasks related to activities involving patient-level data 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, R and/or Python 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 ADaMs.
Ensure timely and accurate completion of Data Engineering deliverables.
Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities.
Must comply with international regulations.
Ensure 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 with the protocol, external/internal standards applicable regulatory guidelines, policies, SOPs, and other relevant 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.
Participate in meeting or teleconferences with vendors by providing advice.
Operational excellence Innovation
Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions
Maintains current knowledge of industry best practice in Data Engineering methodology.
Contribute to the development and maintenance of macros or tools to effectively support programming needs.
May contribute, by partnering with internal and external stakeholders to the optimization of technology, processes and standards, quality/inspection readiness, decrease of project life cycle and cost reduction.
EDUCATION & EXPERIENCE
Degree in statistics, biostatistics, mathematics, epidemiology, data science, computer science or life sciences is required
At least 2 years experience within Pharma, CRO or Medical Device is required
Excellent English language skills
Excellent communication skills, both oral and written, in explaining in simple terms complex concepts
Proven negotiation and project management skills
Demonstrated expertise in study design, conduct and execution
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
Demonstrates entrepreneurship, leadership and proactive problem solving
Previous experience supporting SAS macro, R and/or Python and/or system utility development is highly preferred
Solid knowledge of new advanced statistical methods using SAS
Excellent Benefits
Work-Life Balance
Growth and Development
Health and Wellbeing Support