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Senior Manager Biostatistics
☞ PharmiWeb.jobs: Global Life Science Jobs
View: 173
Update day: 04-04-2024
Category: R & D IT - Software
Industry: Staffing Recruiting
Position: Mid-Senior level
Job type: Full-time
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Job content
Hobson Prior are currently seeking for a Senior Manager Biostatistics to join a fantastic pharmaceutical organisation on a permanent basis located in Nyon. Our client is focused on offering high-quality medicines for those who are suffering from severe illnesses.Please note that to be considered for this role you must have the right to work in this location.Key Responsibilities- For this position, you will partake in the development plans, concept sheets, protocols, Study Reports, Briefing Books, ISS/ISE, submission packages to Authorities (mainly FDA and EMA), and interactions with Health Authorities such as the development of answers to their queries following submissions.
- Responsible for overseeing Statistical Analyses Plans and other statistical deliverables.
- Manage overcome operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues.
- Effectively collaborate with Biometrics colleagues as well as with Pharmacometrician’s for input and information exchange to ensure best practices are implemented across all studies/programs.
- Participate in CRO selection process and provide CRO oversight to achieve high quality deliverables within agreed timelines and budget.
- Provide input to process improvement: assess new methodologies or technologies when applicable; contribute to the development, review, and update of BDM SOPs as company/situations evolve.
- Collaborate effectively with cross-functional teams and external partners.
- Maintain strong and broad-based statistical expertise.
- Any other assigned duties.
- Communication skills both verbally and in writing.
- Highly motivated and enjoys working in a fast-paced environment.
- An organised individual with the ability to prioritise and work on various tasks simultaneously.
- A positive, flexible self-starter who thrives under pressure.
- Educated to a master’s degree (or equivalent) or PhD in Statistics, Biostatistics, or related field.
- At least 10+ years of related industry experience within the functional area.
- Strong SAS knowledge.
- Ability to think beyond the home function, identifying connections between different areas of the organisation to see the broader perspective.
- Expertise in ICH and any other relevant guidance documents (from FDA, EMA, …).
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Deadline: 19-05-2024
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