Senior Statistical Programmer (contract) at Compass Pathways

Dover, New Hampshire, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Jan, 26

Salary

0.0

Posted On

11 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistical Programming, CDISC Expertise, SAS, R, Clinical Development, Quality Control, Regulatory Submission, ICH Guidelines, Problem Solving, Communication Skills, Teamwork, Data Modelling, Interim Analyses, Vendor Liaison, Statistical Analysis Plan, SDTM, ADaM

Industry

Mental Health Care

Description

Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. 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. Roles and Responsibilities (Include but are not limited to): • 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 (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. 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.

Responsibilities

The Senior Statistical Programmer will lead programming activities to deliver accurate clinical data outputs for development programs. This role involves collaboration with study teams and ensuring compliance with regulatory standards.