The Senior Manager, Translational Science Biostatistics will be expected to work independently with minimal supervision, serving as the study statistician for clinical studies. As the study statistician, this individual will be accountable for supporting protocol development and study initiation, developing the SAP and TLG shells, creating variable derivation specifications, SQS plan and DMC charter; providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis; independently reviewing CSRs and performing data interpretation; and supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of new analysis required for responses, and managing CROs. The immediate need is to support Phase I studies and support the Translational Science and Clinical Pharmacology group within the Neurology Business Group (NBG).
Be responsible for the operational aspects of the groups in support of (typically, 1-2) clinical pharmacology studies
*PCS / Clinical Protocol Development reviews whole protocols and interfaces with clinical pharmacologists and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration, etc.
*Statistical Analysis Plan develops SAPs, TLG shells and specifications of variable derivation
*Monitoring develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed)
*Clinical Study Report provides statistical and validation support for analysis datasets, statistical tables, figures and listings performs and validates statistical analysis; independently reviews CSRs and performs data interpretation
*Regulatory interaction supports preparation of inputs for regulatory documents and helps to prepare for meetings with health authorities; drafts responses to health authorities including execution of new analysis required for responses
*Resource Management enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team; may manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines
Provide clinical statistical support for biomarkers and translational science across NBG programs
*Statistical lead in support of collaborations led by Translational Science to evaluate biomarkers across NBG programs
*Assist in planning and analysis of human biomarker datasets to inform biomarker identification and validation, clinical development and business strategies
*Support efforts of Translational Science to generate useful human biomarker data sets from internal (e.g. clinical samples, purchased samples, etc.) and external sources (e.g. ADNI, ROS-MAP, J-ADNI, etc.) as well as promote data and information collection and sharing across NBG programs
*Statistical lead of biomarker analyses and related activities of individual clinical programs
*PhD strongly preferred but combination of education and experience may be considered in lieu of PhD
*Experience in clinical pharmacology, clinical development and/or biomarker development biostatistical methods and processes in industry setting required
*Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process