Biostatistician

JR Italy; Cremona; 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. In this role, you will provide critical statistical input and oversight, ensuring high-quality results to support decision-making. You will collaborate closely with multidisciplinary teams, writing key documents and implementing innovative statistical methodologies. This position offers the opportunity to shape the future of clinical research and make a significant impact in the pharmaceutical industry. If you are passionate about statistics and thrive in a collaborative environment, this role is perfect for you.

Competenze

• Expertise in statistical analysis for clinical studies and development plans.
• Proficiency in SAS and R programming for data analysis.
• Strong knowledge of GCP and ICH guidelines.

Mansioni

• Provide statistical input for clinical study design and analysis.
• Write and review key clinical and statistical documents.
• Act as a statistical representative in cross-functional teams.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Clinical Study Design

Statistical Methodology

Communication Skills

Leadership Skills

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 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 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
6. Contributing to internal process improvements and 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/clinical projects
6. Ability to propose and implement new statistical methodologies
7. Excellent knowledge of GCP and ICH guidelines
8. Excellent communication skills, able to build relationships with stakeholders and explain complex statistical concepts understandably
9. Leadership skills to lead statistical and programming teams
10. Ability 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