Manager (m/f/x) DX-DSS Data Engineering - limited to 2 years

Purpose of the function

• 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. ​​​​​​

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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

Skills and additional Requirements

• 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