Biostatistician

JR Italy; Ascoli Piceno; 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 provide crucial statistical input for clinical studies, collaborating closely with cross-functional teams. Your expertise will drive the design, analysis, and interpretation of clinical data, ensuring high-quality results that support critical decision-making. With a focus on continuous improvement, you'll have the opportunity to propose new methodologies and lead statistical initiatives. This position offers a chance to make a significant impact in the pharmaceutical industry while advancing your career in a supportive environment.

Competenze

• Expertise in statistical input for clinical studies and protocol writing.
• Strong programming skills in SAS and R for data analysis.
• Leadership qualities to guide statistical teams.

Mansioni

• Provide statistical input for clinical study design and analysis.
• Write and review key clinical documents for studies.
• Deliver timely statistical analysis results for decision-making.

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 upskilling 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 are responsible for delivering high-quality analysis results on time to support decision-making. You will oversee and guide statistical activities for teams and outsourcing partners.

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 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 facilitate accurate and prompt decision-making.
4. Serve as a statistical representative within cross-functional study teams and project sub-teams, providing support and solutions.
5. Support the preparation of briefing books, 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. Maintain current knowledge of scientific and regulatory developments.

Support Level 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 knowledge of GCP and ICH guidelines.
• Strong communication skills, capable of building good relationships with internal and external stakeholders and explaining complex statistical concepts understandably.
• Leadership qualities to lead statistical and programming teams.
• Ability to manage, drive, and meet delivery timelines.
• Team-oriented, able to work effectively 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.