Biostatistician

JR Italy; Bergamo; 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 essential statistical input for clinical studies, ensuring timely and accurate analysis to support critical decision-making. You'll collaborate closely with cross-functional teams, contributing to the design and interpretation of clinical data while maintaining high standards of quality. This position offers the opportunity to lead statistical initiatives and drive innovation within the organization, making a significant impact in the pharmaceutical sector. If you have a passion for statistics and a desire to influence the future of healthcare, this is the perfect opportunity for you.

Competenze

• Expertise in statistical analysis and interpretation of clinical study results.
• Proficient in SAS and R programming for data analysis.

Mansioni

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

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodology

Communication Skills

Leadership Skills

Team Collaboration

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 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. Providing 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. Writing and reviewing 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. Providing high-quality and timely statistical analysis results to support correct and timely decision-making.
4. Acting as a statistical representative within cross-functional study teams and project sub-teams, providing statistical support and solutions.
5. Supporting interactions with health authorities and providing input for submissions, publications, and other relevant documents.
6. Supporting internal process improvements and developing new statistical capabilities.
7. Maintaining current scientific and regulatory knowledge.

Competencies required for support level include:

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 statistical methodology knowledge applied to non-clinical, pre-clinical, and clinical projects.
6. Ability to propose and implement new statistical methodologies.
7. Excellent knowledge of GCP and ICH guidelines.
8. Excellent communication skills, capable of explaining advanced statistical concepts to non-statisticians.
9. Leadership skills to lead statistical and programming teams.
10. Ability to manage, drive, and meet delivery timelines.
11. Team player, able to work 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. Extensive experience in submission processes and interaction with health authorities.