Biostatistician

JR Italy; Pisa; 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 pivotal role, you will provide expert statistical guidance for clinical study design and analysis, ensuring high-quality results that support critical decision-making. You will engage with cross-functional teams, lead statistical initiatives, and contribute to regulatory submissions, all while keeping abreast of scientific advancements. This position offers a unique opportunity to influence the development of innovative solutions in the pharmaceutical industry, making a significant impact on patient outcomes.

Competenze

• Expert statistical input for clinical study design and analysis.
• Proficient in SAS and R programming for statistical tasks.

Mansioni

• Provide statistical input for clinical studies and collaborate with stakeholders.
• Write and review clinical and statistical documents for studies.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

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, become part of 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 oversee and guide statistical activities within teams and with 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 essential 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 and 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, responses to health authority requests, publications, and other relevant documents.
6. Engage with health authorities during interactions.
7. Contribute to internal process improvements and the development of new statistical capabilities.
8. Keep current with scientific and regulatory developments in the field.

Support Level Competencies:

• MSc or PhD in Statistics or a related field.
• Experience as a statistician in the pharmaceutical industry.
• Proficiency in English, both oral and written.
• Strong programming skills in SAS (Macro, SQL) and R (functions, packages).
• Robust 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.
• Strong communication skills, capable of explaining complex statistical concepts to non-statisticians and building good relationships with stakeholders.
• Leadership qualities to lead statistical and programming teams.
• Ability to manage, drive, and meet project timelines.
• Team-oriented, able to work effectively in multidisciplinary teams.
• Deep 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.