Senior Principal (m/f/x) DX-DSS Data Engineering (Munich, Germany, 81379) na Europe | Daiichi Sankyo

Purpose of the function

• The 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 Responsibilities

Portfolio program

• Fully 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 responsibility 

• Responsible, 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.

Vendor oversight 

• 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 Innovation

• May 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 Management

• Administrative 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 Education

• BSc 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 Requirements

• Excellent English language skills.
• Excellent 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 the Macro 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.