Senior Biostatistician – Therapeutic Areas, Oncology, Vaccines
Job Description:
• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study
Requirements:
• Experience – Senior Biostatistician (5 Years to 8 Years).
• Primary Skills – Relevant experience as Statistician working on activities like SAP writing, Mock shell creations & Randomization(Good to have), CSR review, Estimand Framework, Bayesian(Good to have).
• Experience on any clinical trial phases with RWE-EHR (Electronic Health Records),claims, registries, R(Proficient) & Efficacy is Mandatory to have.
• CDISC, Sas experience with lead Statistician experience.
• Exp on any Therapeutic areas is okay : Oncology is good to have.
Benefits:
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study
Requirements:
• Experience – Senior Biostatistician (5 Years to 8 Years).
• Primary Skills – Relevant experience as Statistician working on activities like SAP writing, Mock shell creations & Randomization(Good to have), CSR review, Estimand Framework, Bayesian(Good to have).
• Experience on any clinical trial phases with RWE-EHR (Electronic Health Records),claims, registries, R(Proficient) & Efficacy is Mandatory to have.
• CDISC, Sas experience with lead Statistician experience.
• Exp on any Therapeutic areas is okay : Oncology is good to have.
Benefits:
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.