Biostatistician

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

Descrizione del lavoro

An innovative firm is seeking a skilled biostatistician to play a crucial role in clinical studies. This position offers the opportunity to provide expert statistical input, ensuring high-quality analysis results to support decision-making. You'll work closely with stakeholders, design protocols, and lead statistical teams. Join a dynamic environment where your contributions will drive advancements in the pharmaceutical industry, and help shape the future of healthcare through data-driven insights.

Competenze

• MSc or PhD in Statistics or a related field required.
• Experience as a statistician in the pharmaceutical industry is essential.

Mansioni

• Provide statistical input for clinical studies and development plans.
• Write and review key clinical and statistical documents.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

Leadership Skills

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

Key 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], Case Report Form [CRF], Clinical Study Report [CSR]).
3. Delivering 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 support and solutions.
5. Supporting interactions with health authorities.
6. Providing input for internal process improvements and new statistical capabilities.
7. Maintaining current scientific and regulatory knowledge.

Qualifications include:

• MSc. or PhD in Statistics or a related field.
• Experience as a statistician in the pharmaceutical industry.
• Proficiency in English (oral and written).
• Good programming skills in SAS (Macro, SQL) and R (functions, packages).
• Strong knowledge of statistical methodologies applied to non-clinical, pre-clinical, and clinical projects.
• Ability to propose and implement new statistical methodologies.
• Excellent knowledge of GCP and ICH guidelines.
• Excellent communication skills, with the ability to build relationships with stakeholders and explain complex statistical concepts understandably.
• Leadership skills to lead statistical and programming teams.
• Ability to manage and meet delivery timelines.
• Team player, capable of working in multidisciplinary teams.
• Knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10).
• Technical knowledge of CDISC standards (ADaM, SDTM).
• Experience in submission processes and interactions with health authorities.