Programmazione jobs in Italie

As a biostatistician, you will provide expert statistical input and contribute to development plans, design, protocol writing, statistical analysis, and interpretation of results from clinical studies. You are responsible for delivering high-quality analysis results in a timely manner to support decision-making. Additionally, you will offer statistical oversight and guidance to teams and outsourcing partners.

Key tasks and responsibilities include:

1. Providing statistical input to the design, analysis, and interpretation of clinical studies and development plans, collaborating closely with stakeholders such as clinical representatives, safety teams, and data management teams.
2. Writing and reviewing critical clinical and statistical documents, including protocols, SAP, DMP, CRF, CSR, and others.
3. Ensuring the delivery of high-quality and timely statistical analysis results to facilitate correct and prompt decisions.
4. Representing statistics within cross-functional study and project teams, providing support and solutions.
5. Supporting interactions with health authorities and preparing relevant documentation.
6. Contributing to internal process improvements and the development of new statistical capabilities.
7. Maintaining current scientific and regulatory knowledge in the field.

Qualifications and competencies required:

• Master's or PhD in Statistics or related field.
• Experience as a statistician in the pharmaceutical industry.
• Proficiency in English (oral and written).
• Strong programming skills in SAS (Macro, SQL) and R.
• Solid knowledge of statistical methodologies applied to clinical and pre-clinical projects.
• Ability to propose and implement new statistical methodologies.
• Excellent knowledge of GCP and ICH guidelines.
• Strong communication skills for building relationships with stakeholders and explaining complex statistical concepts clearly.
• Leadership skills to guide statistical and programming teams.
• Ability to manage and meet project timelines.
• Team-oriented mindset, capable of working in multidisciplinary teams.
• Deep understanding of regulatory requirements such as ICH E9/E10.
• Technical knowledge of CDISC standards (ADaM, SDTM).
• Experience in submissions and interactions with health authorities.