Statistical Programming Leadership and Innovation Manager
3 giorni fa
We are seeking an experienced Statistical Programming Leadership and Innovation Manager to join our Clinical Data Management Unit at Chiesi Group.
The successful candidate will provide technical leadership and ensure high-quality statistical programming in supporting different phases of clinical development, in compliance with standards and regulatory requirements.
Main Responsibilities:
- To train all statistical computing users, in collaboration with GICT to maintain the platform and evaluate possible innovative solutions.
- To guide the preparation of data packages for regulatory submission, contributing to the strategy, briefing book preparation, regulatory interaction, and overseeing the activities.
- To oversee the execution of all programming activities, reviewing key documents to ensure high-quality reporting is in line with study documents, internal standards, regulatory guidelines/requirements.
- To ensure a consistent approach in CROs management, guiding the internal team and interacting with other internal roles.
- To develop and maintain internal standards and Standard Operating Procedures.
- To support programmers in the review of documents (e.g., Statistical Analysis Plan, Data Review Plan) to ensure clarity and completeness of assumptions and assess impact on programming activity.
- To develop innovative statistical programming approaches and technologies in clinical trials.
- In collaboration with the statistical team, to promote data mining to maximize the value of clinical trial data and support hypothesis generation.
- To build and maintain a network with external statistical and programming teams.
Requirements:
- At least [salary range] per annum, depending on experience.
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