Biostatistician

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

Descrizione del lavoro

An established industry player is seeking a skilled biostatistician to provide expert statistical input for clinical studies. In this dynamic role, you will collaborate closely with cross-functional teams to design and analyze studies, ensuring timely delivery of high-quality results. Your expertise will guide decision-making processes and contribute to internal improvements. This opportunity allows you to lead statistical initiatives while maintaining up-to-date knowledge of scientific and regulatory standards. Join a forward-thinking company that values innovation and teamwork, and steer your career in a direction that excites you.

Competenze

• Expert statistical input for clinical study design and analysis.
• Experience in the pharmaceutical industry as a statistician.
• Strong programming skills in SAS and R.

Mansioni

• Provide statistical input for clinical studies and collaborate with teams.
• Write and review critical clinical documents and reports.
• Deliver high-quality statistical analysis results for decision-making.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Project Management

GCP Guidelines Knowledge

Communication Skills

Leadership

Formazione

MSc in Statistics

PhD in Statistics

Strumenti

SAS

R

Descrizione del lavoro

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Our mission at Akkodis is clear: create a smarter future together! We are a one-stop-shop for engineering, IT, Life Science, and new technologies. Our combined passion for talent and technology allows us to look at the world differently.

With our 360° offer, we support companies in all sectors in implementing Smart Industry solutions, from up- and reskilling entire teams to delivering complete projects.

Our added value? Make the incredible happen!

At Akkodis, you can steer your career in the direction you desire: choose a consulting role, join solutions teams, or be at the forefront of new innovations within our research centres—the choice is yours!

Job Description:

As a biostatistician, you will provide expert statistical input and contribute to development plans, study design, protocol writing, statistical analysis, and interpretation of clinical study results. You are responsible for ensuring the timely delivery of high-quality analysis results to support decision-making. You will also provide statistical oversight and guidance to teams and outsourcing partners.

Key Tasks and Responsibilities:

1. Provide statistical input for the design, analysis, and interpretation of clinical studies, collaborating closely with stakeholders such as clinical representatives, safety teams, and data management teams.
2. Write and review critical clinical and statistical documents, including Protocols, Statistical Analysis Plans (SAP), Data Management Plans (DMP), Case Report Forms (CRF), and Clinical Study Reports (CSR).
3. Deliver high-quality, timely statistical analysis results to support accurate and prompt decision-making.
4. Serve as a statistical representative within cross-functional study teams and project sub-teams, offering statistical support and solutions.
5. Support the preparation of briefing books, regulatory submissions, health authority requests, publications, and other relevant documents.
6. Engage with health authorities as needed.
7. Contribute to internal process improvements and the development of new statistical capabilities.
8. Maintain up-to-date scientific and regulatory knowledge.

Support Level Competencies:

• MSc. or PhD in Statistics or a 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 (functions, packages).
• Solid knowledge of statistical methodologies applied to non-clinical, pre-clinical, and clinical projects.
• Ability to propose and implement new statistical methodologies.
• Excellent understanding of GCP and ICH guidelines.
• Effective communication skills, capable of explaining complex statistical concepts to non-statisticians and building strong relationships with internal and external stakeholders.
• Leadership qualities, with the ability to lead statistical and programming teams.
• Strong project management skills to meet delivery timelines.
• Team-oriented mindset, capable of working within multidisciplinary teams.
• Comprehensive knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10).
• Technical familiarity with CDISC standards (ADaM, SDTM).
• Extensive experience in submissions and interactions with health authorities.