Principal Data Scientist - Biostatistics

GENERAL SUMMARY:

Principal Data Scientist: Biostatistics will report to the VP, Data Science and will focus on providing strategic input and technical expertise on statistical methodology to support the research and development organization for assigned projects They will participate as active members of a cross-functional team to plan, lead and execute the tasks required to support the clinical development for the assigned programs.

RESPONSIBILITIES:

• Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis

• Responsible for the development of statistical analysis plan (SAP), TFL shells and other analysis specifications on assigned studies

• Responsible for the development of randomization schema on assigned randomized studies

• Perform data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure quality analysis conducted per the SAP and specifications

• Responsible for the development of statistical reports summarizing the data analysis results

• Ensure adequate interpretation of data/analysis results and consistency/accuracy of data presentation for study reports and publications

• Provide statistical input, including authoring the relevant sections, to various documents for regulatory submissions (e.g., pre-meeting briefing documents, CSRs) and/or publications

• May act as a statistical programmer for inhouse data analysis as needed

• Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials

• Oversee the biometrics vendors to ensure the prompt and quality statistical deliverables

• Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments

• Contribute to the development of functional-level standards, SOPs, and work instructions and templates

• Represent both biostatistics and statistical programming on study/project teams

• Stay abreast of industry development in biostatistics/statistical programming fields and apply to appropriate systems and processes

• Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education:

• 8 years and a Master's degree; or a PhD with 5 years experience; or equivalent experience

Experience:

• Work experience in biotech/pharmaceutical industry or medical research for a minimum of 8 years (or 4 years for a PhD with relevant training)

• Experience in clinical development

• Experience in ophthalmology and/or biologic/gene therapy a plus

Skills:

• Strong SAS programming skills required with proficiency in SAS/BASE, SAS Macros, SAS/Stat and ODS (proficiency in SAS/SQL, SAS/GRAPH or SAS/ACCESS is a plus)

• Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM, MedDRA, WHODRUG

• Experience with all clinical phases (I, II, III, and IV) is desirable

• Experience with BLA/IND submissions is strongly desirable

• Good understanding of regulatory requirements for submission-related activities (e.g., CDISC, CDASH, eCTD) and CRT packages (e.g., XPTs Define/xml, reviewer's guide, analysis metadata report, executable programs) is desirable

• Proficiency in R programming a plus

• Knowledge of applicable GCP/FDACHMP//ICH/HIPPA regulations

• Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a fast-paced environment with shifting priorities and/or conflicting deadlines

• Proficiency in Microsoft Office Apps, such as WORD, EXCEL, and PowerPoint (familiar with the "Chart" features in EXCEL/PowerPoint a plus)

• Excellent written and verbal communication skills and strong team player with a demonstrated track record of success in a cross-functional team environment

• Proven conceptual, analytical, and strategic thinking

• Good interpersonal and project management skills

• Proactively identifies risks, issues, and possible solutions

Base salary compensation range:

National Range: $182,000/yr - $211,000/yr

Please note that the base salary compensation range and actual salary offered to the final candidate depends on various factors: the candidate's geographical location, relevant work experience, skills, and years of experience.