Senior/Principal Programmer - Standards/Automation

Vera Therapeutics·
United Kingdom
14h ago
SeniorTakedaOncology

Description

<p></p> <div> <p><span style="font-size: 10pt;">The purpose of the role is to provide programming support to the statistics and programming department across a range of projects, therapeutic areas and functional streams within a fixed FSP model. This role will support jHTA work across Oncology, GI2 and NS, ensuring strong coordination with internal ADaM standards teams. The Senior or Principal Programmer may also perform a supervisory role (e.g., line management and/or project management) and will act as a primary point of contact where required.</span></p> <p><span style="text-decoration: underline;"><strong><span style="font-size: 10pt;">Key Responsibilities:</span></strong></span></p> <h3><span style="text-decoration: underline;"><span style="font-size: 10pt;">Technical</span></span></h3> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Strong TLF programming expertise, including advanced use of proc report, transpose and tabulate for complex, ground‑up shell development.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Proficiency in macro programming to support standardized, scalable solutions across therapeutic areas.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Working knowledge of ADaM standards, including the ability to independently read, interpret and modify ADaM specifications.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Review clinical trial documents including protocols, SAPs, CRFs and CSRs.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Author, review and approve TFL shells and dataset specifications.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Read the SAP, assess programming and standards impacts, and propose changes to ADaM specifications where needed.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Identify data issues, anomalies and outliers proactively.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Complete, review and approve CDISC validation reports.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Identify standards‑related issues and resolve or escalate as appropriate.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Maintain awareness of emerging standards and assess potential impact to ongoing and upcoming trials.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Maintain proficiency in SAS and awareness of industry developments.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Maintain study master file documents and ensure all documentation is audit‑ready.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">R programming experience is an advantage for expanded analytical flexibility.</span></li> </ul> <h3><span style="text-decoration: underline;"><span style="font-size: 10pt;">General</span></span></h3> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Lead internal and client‑facing study, project and cross‑functional team meetings effectively.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Present study and programming updates internally and externally.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Share scientific, technical and practical knowledge with team members and colleagues.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Perform all work in full compliance with applicable internal processes, procedures, systems and training.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Build strong collaborative working relationships with both internal teams and FSP partners.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ensure project learnings are captured and shared appropriately.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Develop and deliver internal technical training where appropriate.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Lead or contribute to process improvement initiatives.</span></li> </ul> <h2><span style="text-decoration: underline;"><span style="font-size: 10pt;">Minimum Qualification Requirements</span></span></h2> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">BSc, MSc or PhD in a numerical discipline (or equivalent relevant industry experience).</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">At least 4 years of relevant industry experience.</span></li> </ul> <h2><span style="text-decoration: underline;"><span style="font-size: 10pt;">Other Information / Additional Requirements</span></span></h2> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Strong understanding of the clinical drug development process, relevant disease areas, endpoints and study designs.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ability to work effectively across geographies with 2–3 hours of time‑zone overlap.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience working within an FSP model is advantageous.</span></li> </ul> </div><div class="content-conclusion"><p class="p1"><strong><em>Veramed is a B Corp</em></strong><em> accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.</em></p> <p class="p1"><em>As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.</em></p></div>
Vera Therapeutics

Vera Therapeutics

BIOTECHNOLOGY

Gene Editing Technology

LocationBRISBANE, CA
Employees51-200
Open Jobs13
Gene Therapy
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Pipeline

Provision of information on safe waterN/A
QuestionnairesN/A
Specialized Early Engagement Support ServiceN/A
Prone positionN/A
Nitazoxanide TabletsN/A