It jobs in Italy

Social network you want to login/join with:

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:

• 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).
• 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]).
• Providing high-quality and timely statistical analysis results to support decision-making.
• Acting as a statistical representative within cross-functional study teams and project sub-teams, providing statistical support and solutions.
• Supporting interactions with health authorities.
• Providing input to internal process improvements and/or new statistical capabilities.
• Maintaining current scientific and regulatory knowledge.

Required 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 internal and external stakeholders, and explain advanced statistical concepts understandably.
• Leadership skills, able to lead statistical and programming teams.
• Able to manage, drive, and meet delivery timelines.
• Team player, capable of working in multidisciplinary teams.
• Excellent knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10).
• Technical knowledge of CDISC standards (ADaM, SDTM).
• Strong experience in submission and interaction with health authorities.