Biostatistician

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

Descrizione del lavoro

An established industry player is seeking a skilled biostatistician to join their innovative team. In this role, you will provide expert statistical input for clinical studies, ensuring the timely delivery of high-quality analysis results that support critical decision-making. Collaborating with cross-functional teams, you will write and review essential clinical documents and assist in regulatory submissions. This position offers a unique opportunity to contribute to advancements in the pharmaceutical field while working in a dynamic and supportive environment. If you are passionate about statistics and eager to make an impact, this role is perfect for you.

Competenze

• MSc or PhD in Statistics or a related field required.
• Experience as a statistician in the pharmaceutical industry is essential.
• Strong programming skills in SAS and R are necessary.

Mansioni

• Provide statistical input for clinical studies and development plans.
• Write and review key clinical and statistical documents.
• Deliver high-quality statistical analysis results for decision-making.

Conoscenze

SAS Programming

R Programming

Statistical Methodologies

Communication Skills

Leadership Skills

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, contribute to development plans, design, protocol writing, statistical analysis, and interpretation of results from clinical studies. 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.

Responsibilities:

1. Provide statistical input for 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. Write and review key 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. Assist in preparing documents for regulatory submissions, health authority interactions, publications, and other relevant reports.
6. Support interactions with health authorities.
7. Contribute to internal process improvements and the development of new statistical capabilities.
8. Maintain current knowledge of scientific and regulatory developments.

Required 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.
• Strong communication skills, capable of explaining complex statistical concepts to non-statisticians and building good relationships with stakeholders.
• Leadership skills to lead statistical and programming teams.
• Ability to manage, drive, and meet project timelines.
• Team player with experience working in multidisciplinary teams.
• Excellent knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10).
• Technical knowledge of CDISC standards (ADaM, SDTM).
• Extensive experience in submissions and interactions with health authorities.