We are looking for a Statistical Programmer who is passionate about their profession and inspired by being part of a team, working in life sciences, to bring a therapy to patients. This is an opportunity to make an impact while being part of a historically significant company that is making a difference to the lives of millions of people.
Reporting to the Head of Translational Data Sciences and Advanced Analytics will be responsible for implementing statistical analyses using R and/or SAS and performing quality review of R and SAS programs and deliverables for in-house analyses and out-sourced clinical trials, help with in-house and out-sourced data management, commercial requests and biostatistical ad-hoc analyses.
- Writes R and/or SAS programs to implement statistical analyses (i.e., generating tables, listings, figures, and inferential statistical output) supporting regulatory requests, ISS/ISE analyses, commercial requests, biostatistical ad-hoc analysis
- Performs R and/or SAS programming using more complex techniques such as SAS macro language, advanced data manipulation techniques, and statistical procedures (e.g., PROC GLM, PROC FREQ, PROC REPORT)
- Troubleshoots and provides quality review of complex R and/or SAS programs
- Codes R and/or SAS utility macros; writes and implements test plans to support R and/or SAS macro development
- Helps solve critical issues requiring R and/or SAS expertise
- Performs quality review on R and/or SAS programs generated by other statistical programmers and biostatisticians
- Leads the development of data collection, analysis and reporting standards content and processes
- Produce and deliver standard datasets, program edit checks, quality tables, figures and listings in a timely and high quality fashion
- Provide input in the design and development of clinical trial protocols, case report forms and clinical databases
- Author clinical protocols and biostatistical sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
- Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize study designs
- B.A. / B.S. with at least 5 years relevant experience or an M.S. with 3+ years’ experience in a pharmaceutical/biotech or CRO setting
- Good knowledge of R and SAS, including R and SAS macro language, data manipulation techniques, and statistical procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM)
- Strong organizational skills, attention to detail and the ability to learn technical and clinical aspects of a clinical trial.
- Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Good analytical skills
- Strong verbal and written communication skills
- Ability to multitask and prioritize work
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AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.