Biostatistician

JR Italy; Rimini; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a skilled Biostatistician to provide statistical expertise and guidance in clinical studies. In this role, you will collaborate with cross-functional teams, ensuring high-quality statistical analysis to support decision-making. Your contributions will be vital in writing protocols, analyzing data, and interacting with health authorities. If you have a strong background in statistics, programming skills in SAS and R, and a passion for improving clinical processes, this opportunity is perfect for you. Join a dynamic team where your expertise will make a significant impact on healthcare advancements.

Competenze

• Master's or PhD in Statistics or related field is required.
• Experience in the pharmaceutical industry as a statistician is essential.

Mansioni

• Provide statistical input to clinical study designs and analyses.
• Write and review critical clinical and statistical documents.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

Communication Skills

Leadership Skills

Formazione

Master's in Statistics

PhD in Statistics

Strumenti

SAS

R

Descrizione del lavoro

Job Description: Biostatistician

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.