Head of Statistics

Job title : Head of Statistics
Location : Italy
Job type : Permanent
Salary : €80000 - €90000 per annum + Accomodation, bonus, benefits
Contact name : Yanick Millet
Contact email : yanick.millet@secpharma.com
The company is an international Global Pharma company with more than 80 years of experience and a strong focus on research, development, production and commercialization of innovative therapeutic solutions in the Respiratory, Neonatology, Rare Disease and Special Care Therapeutic Areas. The position could be 100% Home based from Italy

Missions:
- Providing statistical leadership within the clinical statistics department and R&D organization

- Participating into the statistical strategy, clinical development plans and regulatory submissions

- Ensuring statistical methodology and technical guidance, ensuring statisticians have the necessary competencies to carry out their duties

- Sharing statistical expertise to optimize R&D activities, foster implementation of innovative methods and processes

- Leading GCP compliance and support the creation / review and approval of SOPs, as needed


Requirements:
- Solid working experience in managing complex projects and strong experience with submission and regulatory interactions (>=10 years (CROs or Pharmaceutical Companies)

- 5 years experience in line management or in leading very complex projectscts

- Expertise in methodology supporting drug development in all phases of drug development (Phase I-IV)

- Strong experience of regulatory interactions and submissions in Europe and US

- Keen on innovation