Expert Statistical Programming

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;
Any other duties deemed pertinent to the needs of the business.

Personal Skills and Professional Experience:

Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required;
Excellent English language skills High;
Understanding of GCP and GDPR principles Medium;
Good communication skills, both oral and written, in explaining in simple terms complex concepts Medium;
Knowledge of SAS language, procedures and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Medium;
Baseline knowledge of advanced statistical methods using SAS Low;
Knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research. Medium;
Ability and interest to work remotely with worldwide team members across cultures and time zones Medium.

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