Biostatistician

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

Descrizione del lavoro

An established industry player is seeking a skilled biostatistician to join their dynamic team. In this role, you will leverage your expertise in statistical analysis to guide clinical study design and execution. Your contributions will be pivotal in ensuring high-quality results that support critical decision-making processes. This position offers the opportunity to work collaboratively with a variety of stakeholders, enhancing your leadership skills while engaging in innovative projects. As part of a forward-thinking organization, you will play a vital role in shaping the future of clinical research and statistical methodologies.

Competenze

• Expertise in statistical analysis for clinical studies.
• Strong programming skills in SAS and R.
• Experience in regulatory submissions and health authority interactions.

Mansioni

• Provide statistical input for clinical study design and analysis.
• Write and review key clinical documents and protocols.
• Engage with health authorities and support regulatory submissions.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Clinical Study Design

Communication Skills

Leadership

Project Management

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 the up- and reskilling of entire teams to the delivery of complete projects.

Our added value? Make the incredible happen!

At Akkodis, you can take your career into the direction you want: choose a consulting role, become part of solutions teams, or be at the forefront of new innovations from within our own research centres... the choice is yours!

Job Description:

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 on time to support decision-making. You will oversee and guide statistical activities within teams and with outsourcing partners.

Key tasks and responsibilities include:

1. Providing statistical input for the design, analysis, and interpretation of clinical studies and development plans in collaboration with stakeholders such as clinical representatives, safety teams, and data management teams.
2. Writing and reviewing key clinical and statistical documents including protocols, SAP, DMP, PDMP, CRF, and CSR.
3. Ensuring timely delivery of high-quality statistical analysis results to facilitate correct decision-making.
4. Serving as a statistical representative in cross-functional study teams and project sub-teams, offering support and solutions.
5. Supporting the preparation of briefing books, regulatory submissions, health authority inquiries, and publications.
6. Engaging with health authorities during interactions.
7. Contributing to internal process improvements and the development of new statistical capabilities.
8. Maintaining current scientific and regulatory knowledge in the field.

Support Level Competencies:

• MSc. or PhD in Statistics or related field.
• Experience as a statistician in the pharmaceutical industry.
• Proficiency in English (oral and written).
• Good programming skills in SAS (Macro, SQL) and R (functions, packages).
• Strong knowledge of statistical methodologies applied to non-clinical, pre-clinical, and clinical projects.
• Ability to propose and implement new statistical methodologies.
• Excellent knowledge of GCP and ICH guidelines.
• Excellent communication skills, capable of building good relationships with internal and external stakeholders and explaining complex statistical concepts understandably.
• Leadership abilities to lead statistical and programming teams.
• Ability to manage, drive, and meet project timelines.
• Team-oriented, able to work in multidisciplinary teams.
• Excellent understanding of regulatory requirements related to statistics (e.g., ICH E9/E10).
• Technical knowledge of CDISC standards (ADaM, SDTM).
• Extensive experience in submission processes and interactions with health authorities.