Principal Data Scientist - Statistical Programming

GENERAL SUMMARY:

The Principal Data Scientist: Statistical Programmer will report to the VP, Data Science and will focus on applying programming methodology for implementing statistical analyses using SAS for in-house deliverables and performing quality review of outsourced statistical deliverables. 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 programming support to assigned projects, including, as needed, generating programming codes for inhouse data analysis

• Work closely with biostatisticians to review the SAP and be responsible for developing data/analysis program specifications based on the SAP.

• Maintain complete and auditable programming documentation for analysis of clinical trials.

• Contribute to the development, documentation, and maintenance of reusable programming code library

• Collaborate with IT to set up/maintain the statistical computing infrastructure (e.g., SAS server)

• May act as a biostatistician on small-scale projects

• 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, 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:

• 12 years of related experience with a Bachelor's degree; or 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 strongly 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

• Able to run the P21 checks is a plus

• Proficiency in R programming is a plus

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

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

• 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

• 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:

Outside of Bay Area Range: $176,000/yr - $198,000/yr

Bay Area Range: $178,000/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.