Senior Manager Biostatistics

Conteúdo do emprego

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.

Key Skills

• 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.

Requirements

• 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, …).

Apply NowIf you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.