Biostatistician

JR Italy; Chieti; In loco; EUR 45.000 - 75.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a skilled biostatistician to provide expert statistical input for clinical studies. In this role, you will be responsible for designing and analyzing clinical data, ensuring timely and high-quality results that support critical decision-making. You will collaborate closely with cross-functional teams, write essential documents, and maintain regulatory knowledge. This position offers the opportunity to contribute to groundbreaking projects in the pharmaceutical industry and develop new statistical capabilities in a dynamic environment.

Competenze

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

Mansioni

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

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodologies

Communication Skills

Leadership

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. 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], Prescription Drug Monitoring Program [PDMP], 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 and contribute to submissions, publications, and other relevant documents.
6. Support internal process improvements and the development of new statistical capabilities.
7. Maintain current scientific and regulatory knowledge.

Competencies required:

1. MSc. or PhD in Statistics or related field.
2. Experience as a statistician in the pharmaceutical industry.
3. Proficient in English (oral and written).
4. Good programming skills in SAS (Macro, SQL) and R (functions, packages).
5. Strong knowledge of statistical methodologies 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 building good relationships with stakeholders and explaining complex statistical concepts understandably.
9. Leadership qualities, able 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. Extensive experience in submissions and interactions with health authorities.