My Reflection

As I reflect on my journey from an entry-level programmer in 2005 to my current role as Principal & Co-Founder of Clymb Clinical, it dawns on me that success is a climb, not a leap.

The ascent through the ranks – from Sr. Programmer to Principal, Director, VP and eventually starting up Clymb – was not without its challenges. But through it all, I chose the path I believed in. I am grateful for the guidance of my advisor in grad school, the wisdom imparted by my parents/mentors, the collaboration with peers, the dedication of my direct reports, the trust of clients, and the camaraderie of industry colleagues. Last but certainly not least, my family has been my steadfast anchor.

Upon departing from my previous organization in April 2022, I was approached by at least 15 different organizations eager to welcome me into their teams. Interestingly, on the last day of the PHUSE US Connect in March that year, as I shared my decision with the PHUSE Committee, I found myself in conversation with Global Heads of Stats Programming, who offered insights into the needs of their organizations. Approaches came not only from the US but also from the UK, Europe and India. The overwhelming support and respect I received were a testament to the credibility and social network cultivated through two decades of my career and nurtured significantly by my involvement with PHUSE and other social events.

In navigating this climb, I’ve learned to value the significance of planning one’s own journey. I believe taking the time to reflect, envisioning where you want to be in three to five years, and then charting your course today is not just a strategic approach but a compass for personal and professional growth. Dedication, and a commitment to community contributions, have been integral to building credibility – an asset that has proved invaluable for me in securing new opportunities and winning over clients.

It was clear that my passion was to start my own company, and that led me to creating Clymb Clinical. My goal is to develop solutions using the latest technology and CDISC standards to enhance our data processes. This involves developing innovative solutions, encompassing both community and enterprise versions, and providing essential clinical data services. Along this journey, I continue to participate and take leadership roles in CDISC, PHUSE and other industry-wide activities. The experience has been genuinely rewarding and satisfying!

Beyond the professional aspects, my commitment to PHUSE is deeply personal. It stems from a belief in the betterment of the industry and a desire to contribute to a community that has given me so much. I am passionate about giving back, not just for the love of networking but as a firm advocate for the collective improvement of our field.

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My PHUSE Journey

My involvement with PHUSE has been a cornerstone of this odyssey. During the nascent days of PHUSE's expansion into the US, I began as a volunteer, contributing to educational materials. My journey with PHUSE truly commenced during a PHUSE/FDA Computational Science Symposium (CSS) in 2016, when I eagerly signed up to lead the SDTM/ADaM Implementation FAQ project. This ongoing initiative brings industry experts together to address FAQs on CDISC implementation and data submission topics. My role involved technical contribution and building bridges, fostering collaborations with FDA representatives, and curating camaraderie within the PHUSE Community. This project is still active (the longest in PHUSE history so far!), and we are always looking for people to join the team.

In March 2018, I was honored with the PHUSE Individual Outstanding Achievement Award at the CSS, a truly humbling recognition.

That same year witnessed the inauguration of the annual US Connect in Raleigh, NC, where I contributed by authoring and co-authoring multiple white papers with my team in various Streams (Data Visualization, Standards Implementation, Regulatory Submissions, Strategy in Programming) – an experience that added depth to my professional journey and helped me establish myself as a thought leader. The papers presented at the US Connect 2018 are hyperlinked above – for a more complete list of all my papers published since 2008, please visit my profile on LinkedIn.

Since 2018, PHUSE has been a consistent thread in my narrative. Those following me on LinkedIn have witnessed my journey! From serving as a Stream Chair (Analytical Risk-Based Monitoring, Regulatory Submissions, and Panel Discussions) from 2019 to 2022 during the US Connects to co-chairing the event in 2023, and now proudly serving as the US Connect 2024 Chair, each step has been a testament to the Community’s collaborative spirit and my commitment to its growth. I value my involvement with PHUSE, recognizing that its valuable opportunities have contributed to my success.

Come attend a PHUSE event, take the lead and contribute! Remember, volunteering goes beyond your regular job – it’s a commitment, no matter how small. Don’t underestimate the impact of your contribution.

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US Connect 2024

As the US Connect Chair, I am honored to lead an exceptional team, which includes two Co-Chairs (Karnika Dalal and Kirsty Lauderdale) and 57 Stream Chairs, all supported by the PHUSE Office and the PHUSE leadership. The autonomy granted by the PHUSE leadership allows me to lead with flexibility, with their guidance readily available whenever I need it, and the PHUSE Office staff play a key role in our success.

Regular interactions with PHUSE Committee members, who are leaders in their respective organizations, provide excellent opportunities for collaboration and networking. This marks the beginning of your Connect networking journey! If you’re interested in leading a Stream at future Connect events, I highly recommend reaching out to events@phuse.global.

Our motto is simple: ensure high-quality and relevant content. Rooted in innovation, our role as the PHUSE Committee is to bring fresh ideas to the Connect, enhance knowledge, meticulously review content, offer support to presenters, and invite industry leaders. Our goal is the ongoing advancement of our industry.

This year, we have 20 dedicated Streams, some rebranded and three added. I’m fortunate to be supported by my Co-Chairs, and together our main responsibility is to help Stream Chairs with the content selection and curation and ensure the presenters/attendees are fully supported up until the conclusion of the event. Learn about the Streams here.

The upcoming PHUSE US Connect in February 2024 features an exciting agenda with the highest number of submissions we’ve ever received.

Our team reviewed these submissions to curate an incredible agenda, including:

• 150+ presentations
• 30 poster presentations
• 8 Hands-on Workshops
• 3 Leadership Topics
• 3 Panel Discussions
• 2 Interactive Discussions
• 12 PHUSE/FDA Innovation Challenge topics

There will be many other interactive and networking sessions. For more information, check out the video from Karnika, Kirsty here.

Explore the agenda here.

I invite each of you to take the first step, whether as a first-time attendee or a seasoned contributor, to join us at the event! I look forward to welcoming you to the US Connect in February, where we can share experiences, learn from one another, and collectively advance the field of clinical data science. Connect, Learn and Network!

Onwards and upwards.

Bhavin Busa,

Principal & Co-Founder, Clymb Clinical

PHUSE US Connect Chair 2024