Biostatistician

JR Italy; Plasencia; 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 be responsible for designing and analyzing clinical studies, ensuring high-quality results for decision-making. Collaborate with diverse teams, engage with health authorities, and contribute to innovative statistical methodologies. This is a unique opportunity to shape your career while making impactful contributions in the pharmaceutical industry. If you are passionate about statistics and thrive in a collaborative environment, this position is perfect for you.

Competenze

• MSc or PhD in Statistics or related field required.
• Experience in the pharmaceutical industry as a statistician.

Mansioni

• Provide statistical input for clinical study design and analysis.
• Write and review key clinical and statistical documents.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

Leadership

Communication 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 shape your career path: 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.

Responsibilities:

1. Provide statistical input for clinical study design, analysis, and interpretation, 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 decision-making processes.
4. Serve as a statistical representative within cross-functional study teams and project sub-teams, offering support and solutions.
5. Support the preparation of briefing books, regulatory submissions, health authority requests, and publications.
6. Engage with health authorities as needed.
7. Contribute to internal process improvements and development of new statistical capabilities.
8. Maintain current knowledge of scientific and regulatory developments in the field.

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 qualities, with the ability to lead statistical and programming teams.
• Capability to manage, drive, and meet project timelines.
• Team-oriented, able to work effectively in multidisciplinary teams.
• Deep 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.