Associate Director, Biostatistics - Remote Position
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
The Associate Director, Biostatistics acts as a fully independent statistical lead responsible for one or multiple drug projects. This person interacts internally with all members and functions of the study and management teams providing support to the projects, and externally as required with regulatory authorities and key opinion leaders. The senior staff member will supervise and mentor other statisticians or statistical programmers and is accountable for quality of all statistical input and deliverables, including adherence to budget and timelines. Responsibilities
Provides statistical input to clinical teams including design of studies and analyses requiring advanced statistical methodologies Ensures creation of, maintenance and adherence to indication-specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses Develops Statistical Analysis Plan and statistical section of the protocol; ensures statistical analyses performed in accordance with the protocol, SAP, good statistical practice and regulatory guidelines Provides topline reports of study results and is responsible for the data content of the clinical study report Provides adequate vendor oversight of the study deliverables created (e.g., ADAM/SDTM datasets and TFLs) Performs vendor qualification/audits in collaboration with functional management Investigates new statistical methodology and software and provides feedback to department Resource planning and hiring Mentors junior level statisticians and CRO staff Develops and maintains work instructions, guidelines and SOPs Qualifications
Required:
Ph.D. in Statistics Required:
Minimum of 8 years experience applying statistical methods in biomedical research, pharmaceutical or CRO for oncology trials Required:
Ability to visualize the big picture as the independent lead statistician in a regulatory submission Required:
Knowledge of international regulations (ICH, FDA, EMA) Preferred:
Advanced and broad knowledge of statistical methods, with understanding of industry practices related to statistical analysis of clinical data Preferred:
Knowledge of statistical software Preferred:
In-depth familiarity with processes and procedures in data management and SAS programming Skills
Excellent organizational, interpersonal and leadership skills Excellent communication skills; able to clearly communicate statistical issues to a diverse audience Keen eye for detail Dedication to quality and reliability Good negotiation skills Education
Ph.D. in Statistics Additional Requirements
Travel: Some out-of-area and overnight travel may be expected (up to 10%) Physical Demands: The role may require extended periods of sitting and using office equipment; occasional lifting up to 25 pounds; vision and mobility requirements as described
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The Associate Director, Biostatistics acts as a fully independent statistical lead responsible for one or multiple drug projects. This person interacts internally with all members and functions of the study and management teams providing support to the projects, and externally as required with regulatory authorities and key opinion leaders. The senior staff member will supervise and mentor other statisticians or statistical programmers and is accountable for quality of all statistical input and deliverables, including adherence to budget and timelines. Responsibilities
Provides statistical input to clinical teams including design of studies and analyses requiring advanced statistical methodologies Ensures creation of, maintenance and adherence to indication-specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses Develops Statistical Analysis Plan and statistical section of the protocol; ensures statistical analyses performed in accordance with the protocol, SAP, good statistical practice and regulatory guidelines Provides topline reports of study results and is responsible for the data content of the clinical study report Provides adequate vendor oversight of the study deliverables created (e.g., ADAM/SDTM datasets and TFLs) Performs vendor qualification/audits in collaboration with functional management Investigates new statistical methodology and software and provides feedback to department Resource planning and hiring Mentors junior level statisticians and CRO staff Develops and maintains work instructions, guidelines and SOPs Qualifications
Required:
Ph.D. in Statistics Required:
Minimum of 8 years experience applying statistical methods in biomedical research, pharmaceutical or CRO for oncology trials Required:
Ability to visualize the big picture as the independent lead statistician in a regulatory submission Required:
Knowledge of international regulations (ICH, FDA, EMA) Preferred:
Advanced and broad knowledge of statistical methods, with understanding of industry practices related to statistical analysis of clinical data Preferred:
Knowledge of statistical software Preferred:
In-depth familiarity with processes and procedures in data management and SAS programming Skills
Excellent organizational, interpersonal and leadership skills Excellent communication skills; able to clearly communicate statistical issues to a diverse audience Keen eye for detail Dedication to quality and reliability Good negotiation skills Education
Ph.D. in Statistics Additional Requirements
Travel: Some out-of-area and overnight travel may be expected (up to 10%) Physical Demands: The role may require extended periods of sitting and using office equipment; occasional lifting up to 25 pounds; vision and mobility requirements as described
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