Biostatistician

JR Italy; Novara; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a skilled biostatistician to contribute to the design and analysis of clinical studies. In this role, you will provide expert statistical input and ensure timely availability of high-quality analysis results. You'll collaborate with cross-functional teams and support decision-making processes, while also maintaining current scientific knowledge. This position offers the opportunity to influence the development of new statistical methodologies and improve internal processes, making a significant impact in the pharmaceutical industry.

Competenze

• Expertise in statistical input for clinical studies and protocol writing.
• Experience in the pharmaceutical industry with strong statistical methodology knowledge.

Mansioni

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

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodology

Communication Skills

Leadership

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:

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 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.
6. Provide input for internal process improvements and new statistical capabilities.
7. Maintain current scientific and regulatory knowledge.

Support Level Competencies:

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