Senior Principal Programmer

Braveheart Bio

Senior Principal Programmer overseeing CRO programming activities for a biopharmaceutical company. Leading strategic programming for clinical trials and regulatory submissions.

Posted 5/13/2026full-timeSan Francisco • California • 🇺🇸 United StatesSenior💰 $300,000 - $375,000 per yearWebsite

About the role

Key responsibilities & impact

Oversee CRO programming activities, including SDTM, ADaM, TFLs, define.xml, reviewer’s guides, and other clinical study or submission deliverables.
Review CRO programming plans, specifications, datasets, outputs, QC documentation, issue logs, and submission packages.
Ensure programming deliverables are accurate, traceable, reproducible, and compliant with CDISC standards and FDA/EMA expectations.
Serve as the internal programming lead for FDA, EMA, and other regulatory submissions, including support for health authority questions and ad hoc analyses.
Support ongoing study monitoring by reviewing safety, efficacy, DMC, interim analysis, patient profile, and data review outputs prepared by the CRO.
Collaborate with Data Management to support data cleaning, external data review, reconciliation, database lock, and data quality activities.
Work closely with Biostatistics, Clinical Operations, Regulatory, Safety, Data Management, CROs, vendors, and external partners to align timelines, deliverables, standards, and responsibilities.
Coordinate with alliance or development partners on programming-related deliverables, review comments, issue resolution, and submission-readiness activities.
Track CRO performance, identify programming risks, resolve issues, and ensure timely delivery of high-quality outputs.
Provide programming input into protocols, SAPs, data standards, TFL shells, DMC charters, submission plans, and regulatory response strategies.

Requirements

What you’ll need

At least 10 years of experience in clinical statistical programming in biotechnology/ pharmaceutical industry
Strong expertise in SAS, CDISC SDTM/ADaM standards, TFLs, define.xml, SDRG, ADRG, and regulatory submission requirements
Experience overseeing CRO programming deliverables and supporting FDA/EMA submissions
Strong expertise in clinical trials, data management processes, database lock, interim analyses, DMC support, and regulatory responses
Strong written and verbal communication skills with a collaborative, team-oriented approach
Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
Flexible, proactive, and comfortable operating with lean internal resources and contributing hands-on as needed.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Braveheart Bio Website LinkedIn All Job Openings 1 - 10 employees 🧬 Biotechnology 💊 Pharmaceuticals Biotechnology
Pharmaceuticals Braveheart Bio is a clinical-stage biotechnology company focused on transforming the care of hypertrophic cardiomyopathy (HCM) and related conditions. The company is developing investigational therapies that selectively target overactive myosin — a key disease mechanism in HCM — and is advancing a program through global late-stage (Phase 3) clinical development to improve heart performance and patient quality of life. Senior Principal Programmer 🔥 47 minutes ago 🏢🏡 San Francisco – Hybrid 💵 $300k - $375k / year ⏰ Full Time 🟠 Senior 🖥 Software Engineer Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Oversee CRO programming activities, including SDTM, ADaM, TFLs, define.xml, reviewer’s guides, and other clinical study or submission deliverables.
Review CRO programming plans, specifications, datasets, outputs, QC documentation, issue logs, and submission packages.
Ensure programming deliverables are accurate, traceable, reproducible, and compliant with CDISC standards and FDA/EMA expectations.
Serve as the internal programming lead for FDA, EMA, and other regulatory submissions, including support for health authority questions and ad hoc analyses.
Support ongoing study monitoring by reviewing safety, efficacy, DMC, interim analysis, patient profile, and data review outputs prepared by the CRO.
Collaborate with Data Management to support data cleaning, external data review, reconciliation, database lock, and data quality activities.
Work closely with Biostatistics, Clinical Operations, Regulatory, Safety, Data Management, CROs, vendors, and external partners to align timelines, deliverables, standards, and responsibilities.
Coordinate with alliance or development partners on programming-related deliverables, review comments, issue resolution, and submission-readiness activities.
Track CRO performance, identify programming risks, resolve issues, and ensure timely delivery of high-quality outputs.
Provide programming input into protocols, SAPs, data standards, TFL shells, DMC charters, submission plans, and regulatory response strategies. 🎯 Requirements
At least 10 years of experience in clinical statistical programming in biotechnology/ pharmaceutical industry
Strong expertise in SAS, CDISC SDTM/ADaM standards, TFLs, define.xml, SDRG, ADRG, and regulatory submission requirements
Experience overseeing CRO programming deliverables and supporting FDA/EMA submissions
Strong expertise in clinical trials, data management processes, database lock, interim analyses, DMC support, and regulatory responses
Strong written and verbal communication skills with a collaborative, team-oriented approach
Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
Flexible, proactive, and comfortable operating with lean internal resources and contributing hands-on as needed. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Design Verification, Forward Deployed Engineering 🕒 4 days ago OpenAI 201 - 500 🤖 Artificial Intelligence ☁️ SaaS 🏢 Enterprise Website LinkedIn All Job Openings Design Verification Engineer collaborating on semiconductor deployments with OpenAI's Forward Deployed Engineering team. Elevating design verification and fostering customer-focused solutions. 🏢🏡 San Francisco – Hybrid 💵 $162k - $302k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🖥 Software Engineer 🦅 H1B Visa Sponsor Python Senior Manager / Director, Engineering Strategy – Operations 🕒 5 days ago Salesforce 10,000+ employees ☁️ SaaS 🤝 B2B 🤖 Artificial Intelligence Website LinkedIn All Job Openings Key leader for Salesforce Engineering Strategy and Operations driving operational excellence and strategic initiatives. Partnering with leaders to align investments and processes with strategic priorities. 🏢🏡 San Francisco – Hybrid 💵 $150.1k - $273k / year ⏰ Full Time 🟠 Senior 🖥 Software Engineer 🦅 H1B Visa Sponsor Cloud Senior Manager, Engineering – AI Agents 🕒 May 5 Five9 1001 - 5000 ☁️ SaaS 🤖 Artificial Intelligence 📡 Telecommunications Website LinkedIn All Job Openings Senior Manager leading the development of AI Agent software platform at Five9. Responsible for hiring, managing teams, and delivering top-notch AI solutions. 🏢🏡 San Francisco – Hybrid 💵 $133k - $391.5k / year ⏰ Full Time 🟠 Senior 🖥 Software Engineer 🦅 H1B Visa Sponsor Distributed Systems Technical Threat Investigator, Threat Intel Engineering 🕒 May 1 OpenAI 201 - 500 🤖 Artificial Intelligence ☁️ SaaS 🏢 Enterprise Website LinkedIn All Job Openings Technical Threat Investigator at OpenAI conducting investigations into sophisticated threats to AI tech. Working closely with teams to drive improvements in safety and enforcement. 🏢🏡 San Francisco – Hybrid 💵 $234k - $385k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🖥 Software Engineer 🦅 H1B Visa Sponsor Enterprise Applications Developer 🕒 April 22 Abby Care 51 - 200 ⚕️ Healthcare Insurance 👥 B2C Website LinkedIn All Job Openings Enterprise Applications Developer leading the transformation of Salesforce ecosystem at Abby Care. Focus on custom development and integration architecture for family caregiving solutions. 🏢🏡 San Francisco – Hybrid ⏰ Full Time 🟡 Mid-level 🟠 Senior 🖥 Software Engineer Java View More Software Engineer Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

SASCDISC SDTMCDISC ADaMTFLsdefine.xmlSDRGADRGregulatory submission requirementsdata management processesdatabase lock

Soft Skills

strong written communicationstrong verbal communicationcollaborativeteam-orientedability to thrive in fast-paced environmentcomfortable with changeflexibleproactive