Biostatistician

JR Italy; Rovigo; 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 for clinical studies, ensuring high-quality analysis results that support critical decision-making. You will collaborate with cross-functional teams, write key statistical documents, and maintain a strong knowledge of regulatory requirements. This is a fantastic opportunity to contribute to groundbreaking projects while advancing your career in a supportive environment that values innovation and teamwork.

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 designs and analyses.
• Write and review essential clinical and statistical documents.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

Communication Skills

Leadership Skills

Regulatory Knowledge

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 the up- and reskilling of entire teams to the delivery of complete projects.

Our added value? Make the incredible happen!

At Akkodis, you can take your career in the direction you want: choose a consulting role, become part of solutions teams, or be at the forefront of new innovations from within our own research centres... the choice is yours!

Job Description:

As a biostatistician, you will provide expert statistical input and contribute to development plans, design, protocol writing, statistical analysis, and interpretation of results from clinical studies. You are responsible for delivering high-quality analysis results in a timely manner to support decision-making. You will 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 study results, and development plans in collaboration with stakeholders (e.g., clinical representatives, safety team, data management team).
2. Write and review key clinical and statistical documents (e.g., Protocol, Statistical Analysis Plan [SAP], Data Management Plan [DMP], Case Report Form [CRF], Clinical Study Report [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, and publications.
6. Provide input for internal process improvements and development of 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.
• Able to propose and implement new statistical methodologies.
• Excellent knowledge of GCP and ICH guidelines.
• Strong 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 with experience 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 submissions and interactions with health authorities.