Biostatistician

JR Italy; Latina; 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 expert statistical input and contribute to study design, protocol writing, and analysis of clinical study results. You will collaborate closely with various stakeholders, ensuring high-quality analysis results to support critical decision-making. This position offers the opportunity to work on innovative projects within a supportive environment that values your expertise and contributions. If you are passionate about statistics and eager to make an impact in the pharmaceutical industry, this is the perfect opportunity for you.

Competenze

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

Mansioni

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

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

Communication Skills

Leadership Skills

Team Collaboration

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: 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 will ensure timely availability of high-quality analysis results to support decision-making and provide statistical oversight and guidance to teams and outsourcing partners.

Tasks and Responsibilities:

1. Provide statistical input to the design, analysis, and interpretation of clinical studies and development plans, collaborating closely with stakeholders (e.g., clinical representatives, safety team, data management team).
2. Write and review key clinical and statistical documents (e.g., Protocol, SAP, DMP, PDMP, CRF, CSR).
3. Deliver high-quality and timely statistical analysis results to support decision-making.
4. Act as a statistical representative within cross-functional study teams and project sub-teams, providing support and solutions.
5. Support interactions with health authorities and contribute to submissions, briefing books, publications, and other relevant documents.
6. Contribute to internal process improvements and new statistical capabilities.
7. Maintain current scientific and regulatory knowledge.

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).
• 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, with the ability to explain complex statistical concepts to non-statisticians.
• Leadership skills to lead statistical and programming teams.
• Ability to manage, drive, and meet delivery timelines.
• Team player, capable of working 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 submission processes and interactions with health authorities.