Biostatistician

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

Descrizione del lavoro

Join a forward-thinking company as a Biostatistician, where you will provide expert statistical input for clinical studies and development plans. This role involves collaborating with cross-functional teams, ensuring high-quality analysis results, and leading statistical methodologies. You will have the opportunity to enhance your skills in a dynamic environment while contributing to innovative solutions in the pharmaceutical industry. If you are passionate about statistics and thrive in a collaborative setting, this position offers a chance to make a significant impact on healthcare advancements.

Competenze

• Expertise in statistical input for clinical studies and development plans.
• Proficient in SAS and R for statistical analysis and programming.

Mansioni

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

Conoscenze

Statistical Analysis

SAS Programming

R Programming

Statistical Methodology

Communication Skills

Leadership Skills

Team Collaboration

Formazione

MSc. or 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 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. Provide statistical support for briefing books, submissions, health authorities’ requests, publications, and other relevant documents
6. Support interactions with health authorities
7. Provide input to internal process improvements and/or new statistic capabilities
8. Maintain 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. Proficient 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. Able to propose and implement new statistical methodologies
7. Excellent knowledge of GCP and ICH guidelines
8. Excellent communication skills, able to build good relationships with internal and external stakeholders, and explain advanced statistical concepts to non-statisticians
9. Leadership skills, able to lead a statistical and a programming team
10. Able to manage, drive, and meet delivery timelines
11. Team player, able to work 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