senior statistical programmer à Geneva area

publié
contact
Coralyne Saint-Cirel, Genève Professionals Health Care & Life Sciences
type d'emploi
temporary
postuler >

job details

publié
lieu
geneva area
secteur
Life Sciences
type d'emploi
temporary
référence
12014
contact
coralyne saint-cirel, genève professionals health care & life sciences
téléphone
058 201 54 40
postuler >

description du poste

RESPONSABILITIES:  o Ensure completeness, correctness and consistency of clinical and non-clinical programming deliverables in all assigned clinical studies/programs to achieve high quality results in agreement with defined specifications and timelines o Promote and propose standardization and automation of programming related tasks in collaboration with Biostatistics and other departments to improve consistency and efficiency of information management across all programs o Maintain up to date advanced knowledge of programming software (e.g SAS) as well as industry requirements. Track emerging trends and apply them to improve programming support across all programs o Review CRFs/eCRFs and data management specifications documents; Statistical Analysis Plans/mock TLFs and e-submission related documents o Lead data package preparation for electronic submissions. Review CDISC packages (including, SDTMs and ADaMs datasets, define.xml, reviewer’s guides, SAS programs,...) o Subject Matter Expert for audits and inspections o Participate in the selection process of CROs and provide oversight of outsourced activities o Collaborate effectively with cross-functional teams and external partners. o Develop, review, update, and add SOPs as company/situations evolve when applicable

 

PROFILE: o BSc or Master’s degree in computer science, IT, statistics, mathematics  o 10+ years of related industry experience within the functional area o Knowledge of web based Electronic Data Capture and data management systems o Experience with CRO oversight o Advanced SAS experience and proven skills in the use of SAS within a statistical programming environment o Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective o Good knowledge of GxP environment, ICH and other relevant guidance documents (from FDA, EMA,…). Good knowledge of computerized systems validation processes o Thorough understanding of CDISC requirements, data standards principles and data formats accepted by HA o Fluent English