AL Solutions
Senior Associate | Global Contract Market Access & HEOR
My client, a global biopharma, are seeking an Associate Director/ Director, Biostatistics, who will be responsible for providing statistical expertise to all company studies. You will be primarily responsible for the development of protocol and statistical analysis plan, data analysis, data presentation and report writing. You may also be responsible for providing mentorship to junior biostatisticians.
Primary Responsibilities
Working as leading statistician on multiple studies/projects across different therapeutic areas
Contribute to clinical trial design, protocol development and Clinical Study Report (CSR)
Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups
Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others
Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities
Work as biostatistics function representative in clinical projects and studies
Attend project and study team meetings as needed
Support and participate activities related to regulatory requests and meetings as needed
Close communication with functional manager is expected
Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed
Requirements
Ph.D. in Biostatistics or statistics
At least 4 years of pharmaceutical clinical trial experience
In-depth knowledge of clinical trials methodology, regulatory requirements, statistics
Comprehensive experience of SAS programming and R/S language
Ability to effectively collaborate in a dynamic environment
Excellent practical, organizational, interpersonal, oral and written communication skills are a must
Seniority level
Director
Employment type
Full-time
Job function
Other
Industries
Pharmaceutical Manufacturing
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Primary Responsibilities
Working as leading statistician on multiple studies/projects across different therapeutic areas
Contribute to clinical trial design, protocol development and Clinical Study Report (CSR)
Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups
Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others
Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities
Work as biostatistics function representative in clinical projects and studies
Attend project and study team meetings as needed
Support and participate activities related to regulatory requests and meetings as needed
Close communication with functional manager is expected
Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed
Requirements
Ph.D. in Biostatistics or statistics
At least 4 years of pharmaceutical clinical trial experience
In-depth knowledge of clinical trials methodology, regulatory requirements, statistics
Comprehensive experience of SAS programming and R/S language
Ability to effectively collaborate in a dynamic environment
Excellent practical, organizational, interpersonal, oral and written communication skills are a must
Seniority level
Director
Employment type
Full-time
Job function
Other
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr