Biostatistician

JR Italy; Firenze; 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 studies and statistical analysis. This role involves providing expert statistical input, writing key documents, and ensuring high-quality analysis results for decision-making. You will collaborate with cross-functional teams and support interactions with health authorities. If you have a strong background in statistics and a passion for making an impact in the pharmaceutical industry, this is an exciting opportunity to advance your career in a dynamic environment.

Competenze

• Experience as a statistician in the pharmaceutical industry.
• Ability to propose and implement new statistical methodologies.

Mansioni

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

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

Communication Skills

Leadership Skills

Regulatory Knowledge

Formazione

MSc. or 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 into 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 provide expert statistical input and contribute to development plans, design, protocol writing, statistical analysis, and interpretation of results from clinical studies. You are accountable for the timely availability of high-quality analysis results to support decision-making. You provide statistical oversight and guidance to teams and outsourcing partners.

Tasks and responsibilities include:

1. Provide statistical input to the design, analysis, and interpretation of results from clinical studies, and development plans in close interaction 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. Provide 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 statistical support and solutions.
5. Support interactions with health authorities and prepare relevant documents.
6. Contribute to internal process improvements and develop new statistical capabilities.
7. Maintain current scientific and regulatory knowledge.

Minimum competencies required:

1. MSc. or PhD in Statistics or related field
2. Experience as a statistician in the pharmaceutical industry
3. Proficiency in English (oral and written)
4. Good programming skills in SAS (Macro, SQL) and R (functions, packages)
5. Strong knowledge of statistical methodologies applied to clinical projects
6. Ability to propose and implement new statistical methodologies
7. Excellent knowledge of GCP and ICH guidelines
8. Excellent communication skills, with the ability to explain complex statistical concepts clearly
9. Leadership skills to lead statistical and programming teams
10. Ability to manage and meet delivery timelines
11. Team-oriented, able to work in multidisciplinary teams
12. Deep understanding of regulatory requirements (e.g., ICH E9/E10)
13. Technical knowledge of CDISC standards (ADaM, SDTM)
14. Extensive experience in submissions and interactions with health authorities