Full-Time
Principal Data Scientist
Statistical Programming
Updated on 4/26/2024
Develops genetic medicines using evolved vectors
Senior
Oakland, CA, USA
- 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
- Experience in ophthalmology and/or biologic/gene therapy a plus
- 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
- Provide statistical programming support to assigned projects, including, as needed, generating programming codes for in-house 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 in-house double programming to QC as needed) and coordinate the 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 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
4D Molecular Therapeutics, a leader in gene therapy, boasts a pioneering role in the field with its Therapeutic Vector Evolution platform, helping to create tailored treatments in critical areas like ophthalmology, cardiology, and pulmonology. This focus on cutting-edge genetic medicine development not only underscores the company’s commitment to addressing hard-to-treat diseases but also positions it as a hub for professionals keen on contributing to meaningful and life-altering medical advancements. The company’s collaborative, innovation-driven culture ensures it remains at the forefront of biotechnological breakthroughs, making it an appealing workplace for anyone passionate about impacting patient lives through science.
Company Stage
IPO
Total Funding
$595M
Headquarters
Emeryville, California
Founded
2013