Biostatistician

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 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, become part of solutions teams, or be at the forefront of new innovations within our research centers 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 are responsible for delivering high-quality analysis results on time to support decision-making. You will oversee and guide statistical aspects within teams and with outsourcing partners. Responsibilities include: Providing statistical input for the design, analysis, and interpretation of clinical studies and development plans, collaborating closely with stakeholders such as clinical representatives, safety teams, and data management teams. Writing and reviewing key clinical and statistical documents, including Protocols, Statistical Analysis Plans (SAP), Data Management Plans (DMP), Case Report Forms (CRF), and Clinical Study Reports (CSR). Delivering high-quality, timely statistical analysis results to facilitate accurate and prompt decisions. Representing statistics within cross-functional study and project teams, providing support and solutions. Supporting documentation for regulatory submissions, health authority interactions, and publications. Maintaining current scientific and regulatory knowledge. Required Competencies: MSc or PhD in Statistics or a related field. Experience as a statistician in the pharmaceutical industry. Proficiency in English (oral and written). Strong programming skills in SAS (Macro, SQL) and R (functions, packages). Robust knowledge of statistical methodologies applicable to non-clinical, pre-clinical, and clinical projects. Ability to propose and implement new statistical methodologies. Excellent understanding of GCP and ICH guidelines. Strong communication skills, capable of explaining complex statistical concepts to non-statisticians and building good stakeholder relationships. Leadership qualities to lead statistical and programming teams. Ability to manage, drive, and meet project timelines. Team player with experience working in multidisciplinary teams. Knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10). Technical knowledge of CDISC standards (ADaM, SDTM). Extensive experience in submissions and interactions with health authorities. J-18808-Ljbffr

Location: teramo, IT

Posted Date: 5/9/2025