Expert, Evidence Generation Statistical Programming

Expert, Evidence Generation Statistical Programming

Limited to 15 Months

Daiichi Sankyo Europe

Multiple Locations, Europe

The Position:

• The position holder will support end-to-end delivery of Statistical Programming 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 support study lead and partner with internal and external stakeholders to optimize Statistical Programming technology, processes, and standards;
• The position will have a working knowledge of Statistical Programming applications and industry standards, and fundamental technical skills in working with data received from CROs and other third-party vendors.

Roles and Responsibilities:

Study level statistical activities

• Responsible, with supervision, for operational aspects of study activities assigned to Statistical Programming including but not exclusive to SAPs and TFL shells review from a programming perspective, limited contribution to develop SDTMs and ADaM datasets specifications, contribute to develop SAS programs to create SDTM and ADaM datasets and TFLs based upon provided specs;
• Ensure timely and accurate completion of Statistical Programming deliverables;
• Must comply with international regulations and maintain inspection readiness;
• 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.

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 Statistical Programming methodology.

Personal skills and professional experience:

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required;
• No previous experience mandatory;
• Excellent English language skills;
• Understanding of GCP and GDPR principles;
• Good communication skills, both oral and written, in explaining in simple terms complex concepts;
• Knowledge of SAS language, procedures and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH;
• Baseline knowledge of advanced statistical methods using SAS;
• R knowledge is highly preferred but not required;
• Knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research;
• Ability and interest to work remotely with worldwide team members across cultures and time zones.

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