Senior Manager Biostatistics - Global Pharma
Proclinical are recruiting for a Senior Manager Biostatistics - Global Pharma to join a biotech organisation on a permanent basis located in Geneva.
- Guide or be accountable for the supervision of statistical analysis plans and any other statistical deliverables.
- Handle and troubleshoot operational difficulties, GCP compliance, and standardisation working alongside cross-functional associates rendering to the level of expertise.
- Participate in the development plans, idea sheets, protocols, clinical study reports, briefing books, ISS/ISE, proposal package, interacts with health authorities, etc.
- Work alongside cross-functional teams and external partners efficiently.
- Cooperate with biostatistics, programming and data management coworkers as well as pharmacometrician for contributions and information exchange to enable best practices across all studies/programs.
- Partake in CRO selection process and offer CRO oversight to accomplish high quality deliverables in agreed timelines and budget.
- Offer contributions to process improvement: examine new strategies or technologies when suitable; participate in the development, evaluation and update of BDM SOPs as company/situations advance.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to an advanced degree level in a statistics, biostatistics or similar field.
- Demonstrable experience within the relevant functional area.
- Knowledge of SAS.
- Capable of thinking outside the box, recognise connections between various areas of the business to see the wider perspective.
- Expertise on ICH and any other pertinent guidance documents such as from the FDA, EMA, etc.
- Presentation and communications both verbally and in writing.
- A motivate individual who is keen to work within a fast-paced setting.
- An organised individual with the ability to prioritise workload and work on various tasks simultaneously.
- A positive self-starter who is flexible and thrives while under pressure.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on firstname.lastname@example.org
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.