Biostatistician

JR Italy; Verona; 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 through expert statistical analysis and guidance. This role offers the chance to work on innovative projects, providing high-quality analysis results that support critical decision-making. You will collaborate closely with cross-functional teams, ensuring timely and accurate statistical input while maintaining a strong understanding of regulatory requirements. If you are passionate about statistics and eager to make an impact in the pharmaceutical industry, this opportunity is perfect for you.

Competenze

• Expertise in statistical analysis and interpretation for clinical studies.
• Proficient in SAS and R programming for data analysis.

Mansioni

• Provide statistical input for clinical study designs and analyses.
• Write and review key clinical and statistical documents.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodology

Communication Skills

Leadership

Team Collaboration

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 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 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:

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], Prescription Drug Monitoring Program [PDMP], Case Report Form [CRF], Clinical Study Report [CSR]).
3. Provide high-quality and timely statistical analysis results to support correct and timely 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 provide input for submissions, publications, and other relevant documents.
6. Support internal process improvements and the development of new statistical capabilities.
7. Maintain current scientific and regulatory knowledge.

Competencies Required for Support Level:

1. MSc. or PhD in Statistics or related field.
2. Experience as a statistician in the pharmaceutical industry.
3. Proficient in English (oral and written).
4. Good programming skills in SAS (Macro, SQL) and R (functions, packages).
5. Strong statistical methodology knowledge applied to non-clinical/pre-clinical/clinical projects.
6. Able to propose and implement new statistical methodologies.
7. Excellent knowledge of GCP and ICH guidelines.
8. Excellent communication skills, able to build good relationships with internal and external stakeholders, and explain advanced statistical concepts understandably.
9. Leadership qualities, able to lead statistical and programming teams.
10. Able to manage, drive, and meet delivery timelines.
11. Team player, capable of working in multidisciplinary teams.
12. Excellent knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10).
13. Technical knowledge of CDISC standards (ADaM, SDTM).
14. Strong experience in submission and interaction with health authorities.