Standards Engineer

Based in Philadelphia, Pinnacle 21 is a leader in clinical trial data software and services. Our vision is a clean data pipeline that ends in a successful regulatory submission. We're an established startup that builds software to streamline the drug approval process, bringing life-saving medicines to patients faster. Pinnacle 21 is a certified Great Place to Work, and we're looking for motivated talent. Come help us revolutionize clinical trials and streamline the drug approval process. 

Work that matters – When good drugs get delayed to the market, it’s not just money that’s wasted. Every day we save gives that many more patients longer, healthier lives.  

Work autonomously – Enjoy the freedom to develop your talents without being micromanaged. We’ll support you as you add to your skillset and grow to own multiple projects  

Global footprint – We serve a diverse community of users from around the world. Our software is the industry standard for preparing clinical trial data for regulatory submission. 

What you’ll be doing 

As a member of the Standards Engineering team, you will be responsible for the development, implementation and maintenance of industry standards as well as educating and consulting internal and external Pinnacle 21 customers on the in’s outs of both our product as well as its implementation. You will also leverage your domain knowledge and experience in our space to support this multi-disciplinary organization in many areas ranging from product development to customer success and support to thought leadership.

Participate in development of P21 products

• Proposing and leading the implementation of new clinical data standards
• Proposing and leading the implementation of new tools and functionality enhancements of existing systems
• Developing, managing, and implementing validation rules for all data standards and regulatory requirements
• Testing of P21 tools through active use

Provide consultative services to P21 clients

• By helping them with implementation of industry standards (e.g. CDISC) including development and maintenance of clients internal data standards
• Consult customers on best practices by reviewing existing processes and providing recommendations for improvement
• Conduct User training and knowledge transfer

Promote P21 thought leadership

• Preparing papers and presenting them at industry conferences
• Conducting webinars
• Writing blog posts
• Assisting with preparation of white papers and training materials
• Supporting P21 users on forums and social media
• Participating in the industry initiatives like CDISC, PhUSE, HL7, PharmaSUG, etc.

What we’re looking for 

Must

• Minimum 3 years’ experience in biostatistics and/or regulatory submission
• Experience within CDISC, SDTM mapping and/or creation of ADaM datasets, and define.xml files
• Proficient with SAS or R programming
• Strong interpersonal, communication, writing, presentation and facilitation skills
• Detail-oriented with exceptional follow-through and superior organizational skills
• Ability to communicate with technical teams (e.g. developers and engineers) effectively to drive effective issue resolution
• Proven ability to work both independently and as part of a team; experience working as part of a distributed team
• Ability to gain security clearance for governmental contracts
• Must combine the ability of working smart and leveraging your team to get things done
• Willingness and ability to travel (about 10%)
• Positive energy, working smart, getting things done and being a team player
• Come in smiling

Plus

• Willingness and ability for continuous professional development
• Experience within successful implementations of CDISC Standards and preparation of study data for regulatory submissions
• Membership and participation within clinical trials industry user groups

A bit about us  

As clinical trial data are collected and prepared for submission to a health authority, our platform ensures they comply with data standards and are ready for regulatory review. It's used by the FDA, Japan’s PMDA, and global biopharmaceutical sponsors and clinical research organizations to validate clinical trial data. We empower the life sciences industry to ensure clinical data quality or “fitness,” enabling fast and smooth marketing approvals. In fact, it's our platform that drives the FDA’s 21st Century Review Initiative.