Biostatistician

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

Descrizione del lavoro

An innovative firm is seeking a skilled biostatistician to lead statistical input for clinical studies. This role offers the opportunity to work on diverse projects, contributing to study designs and analyses that shape the future of healthcare. You will collaborate with multidisciplinary teams, guiding statistical methodologies and ensuring compliance with regulatory standards. If you have a passion for statistics and a desire to make a meaningful impact, this position is perfect for you. Join a forward-thinking company that values your expertise and supports your career growth in a dynamic environment.

Competenze

• Master's or PhD in Statistics or related field required.
• Experience as a statistician in the pharmaceutical industry is essential.
• Proficiency in SAS and R programming languages.

Mansioni

• Provide statistical input for clinical study design and analysis.
• Write and review key documents like Protocols and Statistical Analysis Plans.
• Ensure timely delivery of high-quality statistical analysis results.

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

Leadership Skills

Communication Skills

Formazione

Master's 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 up- and reskilling entire teams to delivering complete projects.

Our added value? Make the incredible happen!

At Akkodis, you can steer your career in the direction you desire: choose a consulting role, join solutions teams, or be at the forefront of new innovations within our research centres... the choice is yours!

Job Description:

As a biostatistician, you will provide expert statistical input and contribute to development plans, study design, protocol writing, statistical analysis, and interpretation of clinical study results. You will be responsible for delivering high-quality analysis results in a timely manner to support decision-making. Additionally, you will oversee and guide statistical aspects within teams and with outsourcing partners.

Responsibilities include:

1. Providing statistical input for clinical study design, analysis, and interpretation, collaborating closely with stakeholders such as clinical representatives, safety teams, and data management.
2. Writing and reviewing key documents like Protocols, Statistical Analysis Plans (SAP), Data Management Plans (DMP), Case Report Forms (CRF), and Clinical Study Reports (CSR).
3. Ensuring timely delivery of high-quality statistical analysis results to aid decision-making.
4. Representing statistics within cross-functional teams and providing support and solutions.
5. Supporting documentation for submissions, health authority requests, and publications.
6. Interacting with health authorities as needed.
7. Contributing to process improvements and developing new statistical capabilities.
8. Maintaining current scientific and regulatory knowledge.

Support Level Competencies:

1. Master's or PhD in Statistics or related field.
2. Experience as a statistician in the pharmaceutical industry.
3. Proficiency in English (spoken and written).
4. Programming skills in SAS (Macro, SQL) and R (functions, packages).
5. Strong knowledge of statistical methodologies applied to various project types.
6. Ability to propose and implement new statistical methodologies.
7. Excellent knowledge of GCP and ICH guidelines.
8. Strong communication skills to explain complex statistical concepts clearly.
9. Leadership skills to guide statistical and programming teams.
10. Ability to manage and meet project timelines.
11. Team-oriented, capable of working in multidisciplinary teams.
12. Knowledge of regulatory requirements (e.g., ICH E9/E10).
13. Technical knowledge of CDISC standards (ADaM, SDTM).
14. Experience with submissions and interactions with health authorities.