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 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 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 are responsible for delivering high-quality analysis results in a timely manner to support decision-making. You will oversee statistical aspects and guide teams and outsourcing partners. Key responsibilities include: Providing statistical input for the design, analysis, and interpretation of clinical studies and development plans, collaborating with stakeholders such as clinical representatives, safety teams, and data management teams. Writing and reviewing critical clinical and statistical documents, including Protocols, SAP, DMP, PDMP, CRF, and CSR. Delivering high-quality, timely statistical analysis results to enable correct and prompt decisions. Serving as a statistical representative within cross-functional study teams and project sub-teams, offering support and solutions. Supporting interactions with health authorities through documentation and communication. Contributing to internal process improvements and expanding statistical capabilities. Maintaining up-to-date scientific and regulatory knowledge. Qualifications include: Master's 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). Solid knowledge of statistical methodologies applied 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 relationships with stakeholders. Leadership qualities to lead statistical and programming teams. Ability to manage, drive, and meet delivery timelines. Team-oriented mindset, comfortable working in multidisciplinary teams. Deep knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10). Technical expertise in CDISC standards (ADaM, SDTM). Extensive experience in submissions and interactions with health authorities. J-18808-Ljbffr

Location: salerno, IT

Posted Date: 6/16/2025