Compass Pathways plc
Senior Statistical Programmer (contract) East Coast, United States
Compass Pathways plc, New York, New York, us, 10261
Job Overview
The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements. Location:
East Coast, USA or hybrid in our NYC Office. Reports to:
Associate Director, Statistics and Data Management. Type:
Fixed-term contract for 9 months. Responsibilities
Leading and coordinating the programming activities within agreed timelines Managing the reporting of studies internally and externally Programming outputs as stated in the analysis plan Working closely with study team members, mainly with the study statistician Reviewing of the Statistical Analysis Plan (SAP) and shells Create and review SDTM and ADaM study specifications Ensure programs, datasets, outputs are appropriate for regulatory submission Perform simulations and data modelling Perform Interim analyses Liaise with external vendors on deliverables Candidate Profile
Extensive years experience in statistical programming CDISC expertise Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting Experience in performing quality control (QC) checks Extensive knowledge in regulatory submission process Good understanding of ICH guidelines and regulations such as 21 CFR Part 11 Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions Ability to solve challenging problems and provide recommendations to mitigate risk Good communication skills - both written and verbal Team work skills - Including cross-functional and within the Statistics and Data Management Team Benefits & Compensation
For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal Opportunities
Reasonable accommodation: We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants: We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants: Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship
Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.
#J-18808-Ljbffr
The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements. Location:
East Coast, USA or hybrid in our NYC Office. Reports to:
Associate Director, Statistics and Data Management. Type:
Fixed-term contract for 9 months. Responsibilities
Leading and coordinating the programming activities within agreed timelines Managing the reporting of studies internally and externally Programming outputs as stated in the analysis plan Working closely with study team members, mainly with the study statistician Reviewing of the Statistical Analysis Plan (SAP) and shells Create and review SDTM and ADaM study specifications Ensure programs, datasets, outputs are appropriate for regulatory submission Perform simulations and data modelling Perform Interim analyses Liaise with external vendors on deliverables Candidate Profile
Extensive years experience in statistical programming CDISC expertise Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting Experience in performing quality control (QC) checks Extensive knowledge in regulatory submission process Good understanding of ICH guidelines and regulations such as 21 CFR Part 11 Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions Ability to solve challenging problems and provide recommendations to mitigate risk Good communication skills - both written and verbal Team work skills - Including cross-functional and within the Statistics and Data Management Team Benefits & Compensation
For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal Opportunities
Reasonable accommodation: We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants: We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants: Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship
Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.
#J-18808-Ljbffr