Associate Director, Biostatistics
Scorpion Therapeutics, Hartford, Connecticut, United States
Role Summary
The Associate Director, Oncology Biometrics is a skilled biostatistician who can work independently as the study statistician for Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. The person in this role is an individual contributor who specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. Provides statistical input to study designs and can contribute to departmental or cross-functional initiatives to enhance business processes and improve efficiency. Responsibilities
Serve as a study statistician for assigned clinical studies related to one or more clinical programs. Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner. Provide statistical inputs on clinical development plans. Contribute to the development of clinical study protocols and author the statistical sections. Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses. Develop study randomization specification and verification documents as necessary. Perform sample size calculations and assess trial design operating characteristics under various assumptions. Advise the team on the most efficient design to meet study objectives. Review CRFs and edit checks and participate in UAT of different systems. Review dataset programming specifications, key derived variables, and statistical deliverables. Independently derive from source data key efficacy variables and analyses. Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations. Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner. Provide statistical leadership in clinical study team setting. May independently present at department, project team, or Sr. Management meetings. May lead inter-department projects involving other contributors. Qualifications
Demonstrated high aptitude (subject matter expert) in key areas of responsibility, typically a Ph.D. in Statistics, Biostatistics or related field with 5+ years of clinical trials experience, or a master’s degree with 7+ years of experience. High aptitude in FDA/EMA and other regulations; ICH GCP guidelines; drug development process; CDISC standards and implementation guides; statistical methods and applications to clinical trial design and data analysis; programming skills in R and/or SAS; and company SOPs and business practices. Demonstrated ability to develop and deliver multi-mode communications (written, verbal, presentations) to diverse audiences; manage multiple projects; take on new opportunities with urgency and energy; consistently achieve results; adapt to shifting demands; build partnerships; and solve complex problems; plan and prioritize work to meet organizational goals. Preferred Qualifications
Oncology experience Strong statistical research and simulation skills and experience Leadership capabilities including influencing and coaching others, overseeing work of colleagues, and creating business impact Additional Requirements
Work Location: Hybrid, onsite an average of 2.5 days per week
#J-18808-Ljbffr
The Associate Director, Oncology Biometrics is a skilled biostatistician who can work independently as the study statistician for Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. The person in this role is an individual contributor who specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. Provides statistical input to study designs and can contribute to departmental or cross-functional initiatives to enhance business processes and improve efficiency. Responsibilities
Serve as a study statistician for assigned clinical studies related to one or more clinical programs. Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner. Provide statistical inputs on clinical development plans. Contribute to the development of clinical study protocols and author the statistical sections. Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses. Develop study randomization specification and verification documents as necessary. Perform sample size calculations and assess trial design operating characteristics under various assumptions. Advise the team on the most efficient design to meet study objectives. Review CRFs and edit checks and participate in UAT of different systems. Review dataset programming specifications, key derived variables, and statistical deliverables. Independently derive from source data key efficacy variables and analyses. Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations. Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner. Provide statistical leadership in clinical study team setting. May independently present at department, project team, or Sr. Management meetings. May lead inter-department projects involving other contributors. Qualifications
Demonstrated high aptitude (subject matter expert) in key areas of responsibility, typically a Ph.D. in Statistics, Biostatistics or related field with 5+ years of clinical trials experience, or a master’s degree with 7+ years of experience. High aptitude in FDA/EMA and other regulations; ICH GCP guidelines; drug development process; CDISC standards and implementation guides; statistical methods and applications to clinical trial design and data analysis; programming skills in R and/or SAS; and company SOPs and business practices. Demonstrated ability to develop and deliver multi-mode communications (written, verbal, presentations) to diverse audiences; manage multiple projects; take on new opportunities with urgency and energy; consistently achieve results; adapt to shifting demands; build partnerships; and solve complex problems; plan and prioritize work to meet organizational goals. Preferred Qualifications
Oncology experience Strong statistical research and simulation skills and experience Leadership capabilities including influencing and coaching others, overseeing work of colleagues, and creating business impact Additional Requirements
Work Location: Hybrid, onsite an average of 2.5 days per week
#J-18808-Ljbffr