Senior Statistical Programmer (contract)
SeniorStatistics & Data ManagementPsychiatryMay Not Sponsor
Description
<div class="content-intro"><p><span style="font-size: 14pt;"><strong>Company introduction:</strong></span></p>
<p><span style="font-size: 12pt;">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. </span></p>
<p><span style="font-size: 12pt;">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. </span></p>
<p><span style="font-size: 12pt;">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. - </span><a style="font-size: 12pt;" href="https://compasspathways.com/">Compass Pathways</a><span style="font-size: 12pt;">.</span></p></div><p><span style="font-size: 14pt;"><strong>Job overview:</strong></span></p>
<p><span style="font-size: 12pt;">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.</span></p>
<p><span style="font-size: 12pt;"><span style="font-size: 14pt;"><strong>Location:</strong> </span>United Kingdom home based or hybrid in our London Office.</span></p>
<p><span style="font-size: 12pt;"><span style="font-size: 14pt;"><strong>Reports to:</strong></span> Associate Director, Statistics and Data Management.</span></p>
<p><span style="font-size: 12pt;"><span style="font-size: 14pt;"><strong>Type:</strong></span> Fixed-term contract for 9 months.</span></p>
<p><span style="font-size: 14pt;"><strong>Roles and Responsibilities<br></strong><span style="font-size: 12pt;"><em><span data-contrast="none">(Include but are not limited to):</span></em></span></span></p>
<ul>
<li><span style="font-size: 12pt;">Leading and coordinating the programming activities within agreed timelines</span></li>
<li><span style="font-size: 12pt;">Managing the reporting of studies internally and externally</span></li>
<li><span style="font-size: 12pt;">Programming outputs as stated in the analysis plan</span></li>
<li><span style="font-size: 12pt;">Working closely with study team members, mainly with the study statistician</span></li>
<li><span style="font-size: 12pt;">Reviewing of the Statistical Analysis Plan (SAP) and shells</span></li>
<li><span style="font-size: 12pt;">Create and review SDTM and ADaM study specifications</span></li>
<li><span style="font-size: 12pt;">Ensure programs, datasets, outputs are appropriate for regulatory submission</span></li>
<li><span style="font-size: 12pt;">Perform simulations, data modelling and</span><span style="font-size: 12pt;"> interim analyses</span></li>
<li><span style="font-size: 12pt;">Liaise with external vendors on deliverables</span></li>
</ul>
<p><span style="font-size: 14pt;"><strong>Candidate Profile:</strong></span></p>
<ul>
<li><span style="font-size: 12pt;">Extensive years experience in statistical programming</span></li>
<li><span style="font-size: 12pt;">CDISC expertise</span></li>
<li><span style="font-size: 12pt;">Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R</span></li>
<li><span style="font-size: 12pt;">Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting</span></li>
<li><span style="font-size: 12pt;">Experience in performing quality control (QC) checks</span></li>
<li><span style="font-size: 12pt;">Extensive knowledge in regulatory submission process</span></li>
<li><span style="font-size: 12pt;">Good understanding of ICH guidelines and regulations such as 21 CFR Part 11</span></li>
<li><span style="font-size: 12pt;">Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory question</span></li>
<li><span style="font-size: 12pt;">Ability to solve challenging problems and provide recommendations to mitigate risk</span></li>
<li><span style="font-size: 12pt;">Good communication skills - both written and verbal</span></li>
<li><span style="font-size: 12pt;">Team work skills - Including cross-functional and within the Statistics and Data Management Team</span></li>
</ul><div class="content-conclusion"><h2 style="line-height: 1;"><span style="font-size: 14pt;"><strong>Benefits &amp; Compensation:</strong></span></h2>
<p style="line-height: 1;"><span style="font-size: 12pt;">For an overview of our benefits package and compensation information, please visit &nbsp;"<a href="https://compasspathways.com/join-us/">Working at Compass</a>". <strong>&nbsp;</strong></span></p>
<h2 style="line-height: 1;"><span style="font-size: 14pt;"><strong>Equal opportunities:&nbsp;<br></strong></span></h2>
<p style="line-height: 1.2;"><span style="font-size: 12pt;"><strong>Reasonable accommodation<br><br></strong>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.&nbsp;</span></p>
<p style="line-height: 1;"><span style="font-size: 12pt;"><strong>UK applicants</strong></span></p>
<p style="line-height: 1.2;"><span style="font-size: 12pt;">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.</span></p>
<p style="line-height: 1;"><span style="font-size: 12pt;"><strong>US applicants</strong></span></p>
<p style="line-height: 1.2;"><span style="font-size: 12pt;">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.</span></p>
<h2 style="line-height: 1;"><strong><span style="font-size: 12pt;"><span style="font-size: 14pt;">Sponsorship</span>:</span></strong></h2>
<p style="line-height: 1;"><span style="font-size: 12pt;">Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.</span></p>
<h2 style="line-height: 1;"><span style="font-size: 14pt;"><strong>Data Privacy:</strong></span></h2>
<p style="line-height: 1;"><span style="font-size: 12pt;">All data is confidential and protected by all legal and data privacy requirements, please see our recruitment <a href="https://compasspathways.com/recruitment-candidates-privacy-notice/" target="_blank">Privacy Notice</a> to learn more about how we process personal data.</span></p></div>
Compass Pathways
BIOTECHNOLOGY
Psilocybin Therapy
LocationUK - Cheshire
Open Jobs26
Psychiatry
View Company ProfilePipeline
Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)N/A
PsilocybinPhase 2
PsilocybinPhase 2
PsilocybinPhase 2
PsilocybinPhase 2