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, join solutions teams, or be at the forefront of new innovations 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 will ensure the timely delivery of high-quality analysis results to support decision-making. Additionally, you will oversee and guide statistical aspects within teams and with outsourcing partners. Key Tasks and Responsibilities: Provide 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. Draft and review essential clinical and statistical documents, including Protocols, Statistical Analysis Plans (SAP), Data Management Plans (DMP), Case Report Forms (CRF), and Clinical Study Reports (CSR). Deliver high-quality, timely statistical analysis results to facilitate accurate and prompt decision-making. Represent statistical perspectives within cross-functional study teams and project sub-teams, offering support and solutions. Support the preparation of briefing books, regulatory submissions, health authority requests, publications, and other relevant documents. Engage with health authorities as needed. Contribute to internal process improvements and the development of new statistical capabilities. Stay current with scientific and regulatory developments in the field. Required Competencies: MSc or PhD in Statistics or a related field. Experience as a statistician in the pharmaceutical industry. Proficiency in English (spoken and written). Strong programming skills in SAS (Macro, SQL) and R (functions, packages). Robust knowledge of statistical methodologies applied to non-clinical, pre-clinical, and clinical projects. Ability to propose and implement innovative statistical methods. Excellent understanding of GCP and ICH guidelines. Outstanding communication skills, capable of building relationships with internal and external stakeholders and explaining complex statistical concepts understandably. Leadership qualities, including the ability to lead statistical and programming teams. Strong project management skills to meet deadlines. Team-oriented, with the ability to work effectively 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 submission processes and interactions with health authorities. J-18808-Ljbffr

Location: provincia-di-lecce, IT

Posted Date: 5/20/2025