3 Statistical Design Jobs

We are seeking a Sr Biostatistician to join a leading biopharmaceutical solutions organization. The ideal candidate will provide statistical support throughout the clinical trial lifecycle, from protocol development to the Clinical Study Report (CSR). This role involves preparing Statistical Analysis Plans, coordinating project activities, and serving as a key biostatistics representative on project teams. Roles and Responsibilities Provide support across all assigned statistical tasks during the lifecycle of a clinical trial project, from protocol development to the Clinical Study Report (CSR). Prepare Statistical Analysis Plans (SAPs) , including the development of well-presented mock-up displays for tables, listings, and figures. Coordinate the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high-quality work. Provide independent review of project work produced by other biostatisticians in the department. Create or review programming specifications for analysis datasets, tables, listings, and figures. Review SAS annotated case report forms (CRFs) and other study documentation to ensure all data is captured to support the planned analysis. Conduct and participate in the verification and quality control of project deliverables. Serve as the biostatistics representative on project teams, managing scheduling, time constraints, and proactively communicating any difficulties. Monitor progress on study activities against milestones and ensure project timelines are met. Provide statistical programming support as needed. Support business development activities by contributing to proposals and budgets. Coach and mentor other Biostatistics staff. Follow applicable SOPs, WIs , and relevant regulatory guidelines ( ICH ). Maintain well-organized and up-to-date project documentation to ensure inspection readiness. Skills Required A graduate degree in biostatistics or a related discipline. Proven experience in clinical trials. Proficiency in programming . Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines , and programming techniques utilized in clinical research. Experience across all statistical tasks required to support clinical trials, from protocol to CSR. Excellent written and verbal communication skills. The ability to effectively communicate complex statistical concepts.

We are seeking a Sr Biostatistician to join a leading biopharmaceutical solutions organization. The ideal candidate will provide statistical support throughout the clinical trial lifecycle, from protocol development to the Clinical Study Report (CSR). This role involves preparing Statistical Analysis Plans, coordinating project activities, and serving as a key biostatistics representative on project teams. Roles and Responsibilities Provide support across all assigned statistical tasks during the lifecycle of a clinical trial project, from protocol development to the Clinical Study Report (CSR). Prepare Statistical Analysis Plans (SAPs) , including the development of well-presented mock-up displays for tables, listings, and figures. Coordinate the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high-quality work. Provide independent review of project work produced by other biostatisticians in the department. Create or review programming specifications for analysis datasets, tables, listings, and figures. Review SAS annotated case report forms (CRFs) and other study documentation to ensure all data is captured to support the planned analysis. Conduct and participate in the verification and quality control of project deliverables. Serve as the biostatistics representative on project teams, managing scheduling, time constraints, and proactively communicating any difficulties. Monitor progress on study activities against milestones and ensure project timelines are met. Provide statistical programming support as needed. Support business development activities by contributing to proposals and budgets. Coach and mentor other Biostatistics staff. Follow applicable SOPs, WIs , and relevant regulatory guidelines ( ICH ). Maintain well-organized and up-to-date project documentation to ensure inspection readiness. Skills Required A graduate degree in biostatistics or a related discipline. Proven experience in clinical trials. Proficiency in programming . Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines , and programming techniques utilized in clinical research. Experience across all statistical tasks required to support clinical trials, from protocol to CSR. Excellent written and verbal communication skills. The ability to effectively communicate complex statistical concepts.

Desired Experience Experience of biostatistics in regulated markets Interacted with regulatory agencies (FDA/EMA/PMDA) Experience of biosimilar product development Knowledge of statistical models, meta-analysis, regression, longitudinal data analysis Knowledge of using relevant software including PASS, SAS, SPSS, R Job Description Prepare scientifically sound statistical design for clinical trials Design clinical trials for biosimilars for global requirements (FDA/EMA/PMDA) Perform meta-analysis and calculate sample size Prepare statistical justifications for agency interactions (FDA/EMA/PMDA) Review and provide inputs to statistical sections of clinical trial protocol Plan and perform blinded sample size re-estimation and interim analysis Review and provide inputs to statistical analysis plan and CRF Review tables, listings, figures and clinical study reports Collaborate with internal and external stakeholders (CROs) to resolve issues around statistics Respond to agency queries on issues related to biostatistics Qualification : MSc., PhD in Biostatistics Experience : 10-15 years' experience in a Pharma / CRO