Ividata Life Sciences

Consultant

• Work on high-value projects as a Medical Writer
• Draft and review regulatory clinical documents
• Collaborate with Clinical, Regulatory and Medical Affairs teams
• Perform quality control of complex documents
• Contribute to scientific monitoring and writing processes

Consultant Medical Writer

Project Manager

• Lead the execution of the global submission plan across the entire product lifecycle
• Anticipate operational risks and manage planning and timelines
• Structure the dossier hierarchy and coordinate the collection of documents
• Oversee publishing vendors and coordinate the preparation of responses to health authority queries

Consultant – Regulatory Affairs Project Manager

• Define the most appropriate statistical methodology
• Participate in selecting analysis strategies and calculate the required sample size
• Draft, review and validate the statistical sections of clinical protocols and the Statistical Analysis Plan (SAP)
• Contribute to writing synopses and scientific documents
• Perform analyses and carry out statistical programming in SAS or R
• Ensure the production and delivery of deliverables and datasets on time, in accordance with quality standards and in CDISC format
• Be responsible for the completion, filing and compliance of the eTMF for the statistical section
• Summarize, model and interpret the results of clinical analyses
• Collaborate closely on a day-to-day basis with physicians and clinical teams
• Review and approve all external scientific communications related to the studies

Consultant – Clinical Biostatistician, RWE

• Review of synopses and protocols
• Supervision of statistical deliverables produced by external providers
• Monitoring the progress of statistical operations
• Ensure delivery of TFLs and results within agreed timelines
• Delivery of analysis datasets

Consultant, RWE Biostatistician

Public Relations

• Draft and review preclinical study synopses
• Coordinate the operational execution and logistics of studies with CROs
• Analyze and interpret bioanalytical data
• Ensure compliance with protocols and timely delivery of study reports
• Assess CRO technical capabilities, negotiate and manage contracts
• Contribute to the collection of PK/PD data and the nonclinical PK strategy
• Review and validate TK/PK documents for regulatory submissions

Consultant Medical Writer

Consultant – Regulatory Affairs Project Manager

Consultant – Clinical Biostatistician, RWE

Consultant, RWE Biostatistician

Consultant, Preclinical Pharmacokinetics