Biostatistics Manager

2 giorni fa

Milano, Italia Warman O'Brien A tempo pieno

**Biostatistics Manager - Global CRO - Italy / Europe**

We have recently partnered with an award winning, patient centric CRO, who are looking for an experienced Manager of Biostatistics to join their successful study delivery team.

The role would suit an experienced Principal level Biostatistician to join the biometrics department in EMEA as a Biostatistics Manager.

**Desirable Experience**
- Serves as (or mentors/coordinates staff in the roles of) lead statistician
- Work as project lead, or senior reviewer on multiple projects
- Manage project team resources, budget, finance, timelines and ensures SOP compliance
- Serves as (or mentors others in the role of) randomization statistician on selected projects.
- Provides expert knowledge and mentoring on statistical and regulatory issues, development/delivery of training, and implementation of best practices for the department.
- Prepares and reviews statistical reports, clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports.
- Serves as senior reviewer on moderate or complex studies as assigned.
- Experience in sponsor management
- Provides technical input/writing into study design and statistical considerations during protocol development or review, SAP development/review, and provides expert knowledge and experience of complex trials design across different therapeutic areas.

**Key Qualifications and Skills**
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7+ years’).
- Master’s degree in statistics, biostatistics, mathematics or related field
- Demonstrated initiative and motivation
- Strong knowledge of SAS® and clinical biostatistics
- Capable of leading complex projects
- Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff
- Strong verbal and written communication skills
- Strong understanding of the drug development process and FDA regulations

**What you get in return**
- Ongoing development is vital, and as a Manager of Statistics you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.
- In comparison with their competitor’s and pharmaceutical companies, they provide more flexible working platforms for coaching and educating newcomers to be highly respected professionals in our industry.

**Salary**: €60,000.00 - €80,000.00 per year

Ability to commute/relocate:

- Milano, Lombardia: Reliably commute or planning to relocate before starting work (preferred)

**Education**:

- Master's (preferred)

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