Biostatistician

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

Descrizione del lavoro

An established industry player is seeking a skilled biostatistician to contribute to clinical study designs and analyses. In this role, you will provide essential statistical insights, draft critical documents, and ensure high-quality results for informed decision-making. Your expertise in SAS and R will be pivotal in collaborating with cross-functional teams and engaging with health authorities. Join a forward-thinking organization that values innovation and teamwork, and steer your career towards impactful contributions in the pharmaceutical sector.

Competenze

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

Mansioni

• Provide statistical input for clinical studies and development plans.
• Draft and review clinical documents like Protocols and SAP.
• Deliver timely statistical analysis results for decision-making.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Project Management

Communication Skills

Leadership

Knowledge of GCP and ICH

Statistical Methodologies

Formazione

MSc in Statistics

PhD in Statistics

Strumenti

SAS

R

SQL

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 will ensure the timely delivery of high-quality analysis results to support decision-making. Additionally, you will oversee and guide statistical aspects within teams and with outsourcing partners.

Key Tasks and 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. Draft 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, timely statistical analysis results to facilitate accurate and prompt decision-making.
4. Represent statistical perspectives 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, 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. Stay current with 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 (spoken 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 innovative statistical methods.
• Excellent understanding of GCP and ICH guidelines.
• Outstanding communication skills, capable of building relationships with internal and external stakeholders and explaining complex statistical concepts understandably.
• Leadership qualities, including the ability to lead statistical and programming teams.
• Strong project management skills to meet deadlines.
• Team-oriented, with the ability to work effectively in multidisciplinary teams.
• Deep knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10).
• Technical expertise in CDISC standards (ADaM, SDTM).
• Extensive experience in submission processes and interactions with health authorities.