Principal Statistical Programmer
COMPASS Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin is administered in conjunction with psychological support.
Our vision is a world of mental wellbeing. COMPASS Pathways.
The Principal Programmer/Statistical Programmer will be responsible for providing expert technical guidance and input into COMPASS Pathways development programs.
Location: United Kingdom (home based) or hybrid in our London Office.
Reports to: Senior Director, Statistics and Data Management.
Roles and 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 the SAPs and shells
- Create study specifications
- Review SDTM and ADaM specifications
- Ensure programs, datasets, outputs are appropriate for regulatory submission
- Perform simulations and data modelling
- Perform Interim analyses
- Liaise with external vendors
- Extensive years experience
- CDISC expert
- Proficient In programming (including performing statistical analyses and creating macros) in SAS, preferably R
- Programming/reporting expert across of all phases of clinical development (efficacy/safety/PK), including ISS & ISE
- Perform QC checks
- Extensive knowledge in regulatory submission process
- Good understanding of ICH guidelines and regulations such as 21 CFR Part 11
- 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:
Check our "Working at COMPASS" section of our website for more information.
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.
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 (including pregnancy, childbirth, and related medical conditions), ethnicity, 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.