Job
Description
Role & responsibilities : Collaborating with cross-functional teams (e.g., clinical researchers, medical experts, data scientists) to design clinical studies and research protocols. Developing statistical analysis plans (SAP), including the identification of primary and secondary endpoints, sample size calculations, and statistical methodologies. Ensuring statistical methods are aligned with regulatory requirements and industry standards, especially in clinical trials. Providing expertise on randomization techniques and adaptive designs. Leading the analysis of complex datasets, including data from clinical trials, epidemiological studies, and observational studies. Ensuring proper data cleaning, transformation, and validation processes are followed to guarantee the integrity of the data. Using advanced statistical software and techniques (e.g., R, SAS, STATA) to perform statistical modeling (e.g., regression models, survival analysis, mixed models). Analyzing and interpreting results, ensuring conclusions are scientifically sound, and communicating findings in a clear, concise manner. Developing and applying advanced statistical methodologies and techniques tailored to specific study needs, such as longitudinal analysis, survival analysis, or Bayesian methods. Assessing and adapting statistical methods as necessary based on emerging data or evolving study designs. Participating in regulatory meetings and discussions, providing statistical justification for study results and approaches. Mentoring and providing guidance to junior biostatisticians and other team members on statistical methodologies, software, and best practices. Developing training materials and conducting workshops on statistical topics for internal teams and collaborators. Ensuring statistical methods and processes are consistent with industry best practices and organizational standards. Conducting quality control procedures on statistical analyses to verify results and ensure accuracy and validity. Preparing statistical reports, manuscripts, presentations, and posters for scientific journals, conferences, and internal stakeholders. Clearly presenting complex statistical results to non-statistical audiences (e.g., clinical or regulatory teams), ensuring the results are understood and actionable. Working closely with other teams, including clinical researchers, project managers, and data scientists, to ensure the alignment of statistical analyses with research objectives. Actively participating in meetings, strategy sessions, and research reviews to provide statistical insights that can influence study direction and design. Translating statistical findings into actionable recommendations for decision-making. Ensuring that statistical analyses comply with ethical standards and regulatory requirements (e.g., Good Clinical Practice (GCP), Good Statistical Practice (GSP)). Supporting the development of ethical guidelines for statistical methodologies, including ensuring patient safety and data confidentiality. Additional Skills: SAS Programming R Programming (Optional) Advanced knowledge of biostatistics, including statistical theory, methods, and applications. Proficiency in statistical software such as SAS, R, and STATA. Strong communication skills, especially in translating complex statistical concepts into practical recommendations. Attention to detail and the ability to ensure the quality and accuracy of analyses. Experience with clinical trials and regulatory submissions is often critical Qualifications: Master's Degree (Preferred): A Master's in Biostatistics, Statistics, Public Health, or a related field is commonly required for many biostatistician roles, especially in CRO, research institutions, pharmaceutical companies, or public health organizations
