Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products.
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 generating programming codes for in-house data analysis.
- Work closely with biostatisticians to review the SAP and develop 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 prompt and quality statistical deliverables.
- Provide quality review of outsourced statistical deliverables 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.
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.
- Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM.
- 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.
- Proficiency in R programming is 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.
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