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Company

Original Job Post

4D Molecular Therapeutics · 2 days ago

Principal Data Scientist - Statistical Programming

Emeryville, CA

Full-time

Hybrid

Senior Level

$176K/yr - $198K/yr

12+ years exp

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BiotechnologyGenetics

H1B Sponsorship

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Responsibilities

Provide statistical programming support to assigned projects, including generating programming codes for in-house data analysis

Work closely with biostatisticians to review the SAP and develop data/analysis program specifications

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)

Act as a biostatistician on small-scale projects

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

Oversee biometrics vendors to ensure quality statistical deliverables

Provide quality review of outsourced statistical deliverables and coordinate in-house 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 developments in biostatistics/statistical programming fields and apply to appropriate systems and processes

Perform other duties as assigned

Qualification

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Clinical developmentSAS programmingSAS/BASESAS MacrosSAS/StatODSSAS/SQLSAS/GRAPHSAS/ACCESSCDISC standardsSDTM standardsADaM standardsMedDRAWHODRUGClinical trial phasesBLA/IND submissionsRegulatory requirementsSubmission-related activitiesCRT packagesGCP regulationsFDA regulationsICH regulationsHIPAA regulationsMicrosoft OfficeWORDEXCELPowerPointChart featuresCross-functional team environmentProblem-solving

Required

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

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

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

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

Preferred

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

Able to run the P21 checks is a plus

Proficiency in R programming is a plus

Proficiency in SAS/SQL, SAS/GRAPH or SAS/ACCESS

Proficiency in R programming

Company

4D Molecular Therapeutics

4D Molecular Therapeutics designs, develops, and commercializes transformative gene therapeutic products for unmet medical conditions.

Founded in 2013

Emeryville, California, USA

51-200 employees

http://www.4dmoleculartherapeutics.com

H1B Sponsorship

4D Molecular Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2022 (2)

2021 (4)