BioSpace
Associate Director, Data Analytics Science
BioSpace, San Rafael, California, United States, 94911
Overview
Associate Director, Data Analytics Science — BioSpace BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. The Data Analytics Science team provides statistical application development leadership, data standards oversight, and programming analysis across all molecules, leading execution for all phases of clinical trials and drug development, including regulatory submissions. About the Opportunity
The Associate Director will provide statistical programming leadership and oversight for clinical trials, including regulatory submissions, and statistical application development. This individual is responsible for production of statistical programming deliverables, either personally or by directing and coordinating activities of others, or by supervising programming managers, programmers, and partnering with vendors and third parties as applicable. Responsibilities
Lead project programming team to develop datasets (ADaM) and TLGs for clinical study reports, submissions (NDA/BLA) to regulatory agencies (e.g., FDA, EMA), publications, ad hoc and other statistical analysis requests; carry out integrated analyses if assigned. Build effective working relationships with cross-functional groups within Data Science and across BioMarin to ensure stakeholder needs are met. Ensure processes and procedures are carried out in a compliant and consistent manner according to published guidelines for all assigned compounds. Effectively utilize assigned resources and manage deliverables to meet project timelines. Manage CRO and FSP programmers study activities; review programming deliverables; conduct program development and verification; identify bugs and resolve technical problems; identify new tools to increase efficiency and quality. Monitor compliance with departmental procedures and industry standards during all aspects of work. Investigate trends and recommend new methods and technologies used in pharmaceutical/biotech reporting and management of clinical data. Leadership Responsibilities
Provide leadership for departmental strategic initiatives and process improvement. Guide career growth and development opportunities for analysts and programmers. Monitor project progress and ensure proper resource allocation for successful deliverables against goals and timelines. Manage and review contractors’ deliverables as necessary. Minimum Requirements
Master’s degree (preferred) or BA/BS in computer science, statistics, biostatistics, mathematics, or related scientific discipline. 12+ years of clinical trial experience, statistical programming, and/or drug development experience with BA/BS; 10+ years with Master’s. Good knowledge of CDISC standards and programming in SAS. Experience with regulatory submissions. Experience managing others, including managers of statistical programmers. Nice To Have
Master’s degree in related disciplines. Experience with programming in R or Python. Note: This description describes the general nature of the job and may include other duties as assigned. Equal Opportunity
Equal Opportunity Employer/Veterans/Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Seniority level
Director Employment type
Full-time Job function
Engineering and Information Technology Industries
Internet News
#J-18808-Ljbffr
Associate Director, Data Analytics Science — BioSpace BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. The Data Analytics Science team provides statistical application development leadership, data standards oversight, and programming analysis across all molecules, leading execution for all phases of clinical trials and drug development, including regulatory submissions. About the Opportunity
The Associate Director will provide statistical programming leadership and oversight for clinical trials, including regulatory submissions, and statistical application development. This individual is responsible for production of statistical programming deliverables, either personally or by directing and coordinating activities of others, or by supervising programming managers, programmers, and partnering with vendors and third parties as applicable. Responsibilities
Lead project programming team to develop datasets (ADaM) and TLGs for clinical study reports, submissions (NDA/BLA) to regulatory agencies (e.g., FDA, EMA), publications, ad hoc and other statistical analysis requests; carry out integrated analyses if assigned. Build effective working relationships with cross-functional groups within Data Science and across BioMarin to ensure stakeholder needs are met. Ensure processes and procedures are carried out in a compliant and consistent manner according to published guidelines for all assigned compounds. Effectively utilize assigned resources and manage deliverables to meet project timelines. Manage CRO and FSP programmers study activities; review programming deliverables; conduct program development and verification; identify bugs and resolve technical problems; identify new tools to increase efficiency and quality. Monitor compliance with departmental procedures and industry standards during all aspects of work. Investigate trends and recommend new methods and technologies used in pharmaceutical/biotech reporting and management of clinical data. Leadership Responsibilities
Provide leadership for departmental strategic initiatives and process improvement. Guide career growth and development opportunities for analysts and programmers. Monitor project progress and ensure proper resource allocation for successful deliverables against goals and timelines. Manage and review contractors’ deliverables as necessary. Minimum Requirements
Master’s degree (preferred) or BA/BS in computer science, statistics, biostatistics, mathematics, or related scientific discipline. 12+ years of clinical trial experience, statistical programming, and/or drug development experience with BA/BS; 10+ years with Master’s. Good knowledge of CDISC standards and programming in SAS. Experience with regulatory submissions. Experience managing others, including managers of statistical programmers. Nice To Have
Master’s degree in related disciplines. Experience with programming in R or Python. Note: This description describes the general nature of the job and may include other duties as assigned. Equal Opportunity
Equal Opportunity Employer/Veterans/Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Seniority level
Director Employment type
Full-time Job function
Engineering and Information Technology Industries
Internet News
#J-18808-Ljbffr