The Evolving Role of Statisticians in the Pharmaceutical Industry: EFSPI's Contribution to Excellence

Justine Rochon on behalf of EFSPI

The pharmaceutical industry is witnessing a transformative era where statistical innovation and artificial intelligence are reshaping the landscape of drug development, including not only regulatory science but also health technology assessment. In this context, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) plays a pivotal role. Founded in 1992, EFSPI serves as a non-profit umbrella organization for ten national statistical associations, representing approximately 4,000 professionals across Europe.

EFSPI's Mission and Vision

EFSPI's mission is to uphold professional standards and enhance the stature of the statistical profession within the European pharmaceutical industry. By providing collective expert input on statistical matters to national and international authorities, EFSPI ensures that the voice of statisticians is heard in crucial discussions and considered in policy making. The organization also fosters the exchange of information and harmonization of statistical practices among its member groups.

A Brief History

The federation's journey began in 1990, with the official launch following in 1992. Over the years, EFSPI has grown to include 10 member groups from different European countries. Each member organization has two representatives in EFSPI’s Council. The organization has maintained its focus on professional standards and collaboration through regular council meetings and the establishment of special working and interest groups to tackle industry-specific scientific and leadership challenges.

Engaging with the Community

EFSPI's commitment to the community is evident through its various initiatives. For example, the European Special Interest Groups (ESIGs) play a crucial role in connecting professionals across disciplines and fostering collaboration on joint topics of interest. For more information, please visit https://efspi.org/EFSPI/SIGS/EFSPI/Special_Interest_Groups/SIGS.aspx.

Another example is the Statistics Leaders Forum, which was established in 2010 and brings together senior leaders to address strategic challenges and share leadership developments within the industry. This year’s 16th annual Statistics Leaders Meeting will take place from 12th to 13th May 2025, in Copenhagen, Denmark.

Lastly, in September 2023, EFSPI launched the Statistical Methodology Leaders Group to connect statistical methodology leaders across Europe. This initiative focuses on sharing best practices, developing and deploying new statistical methods, and implementing statistical innovation within organizations. It aims to anticipate future trends, drive innovation, manage stakeholder relationships, and inspire talent seeking non-traditional career paths. The group fosters collaboration and critical strategic thinking in statistical methodology through regular meetings and interactions with key stakeholders. For more details, please visit https://efspieurope.github.io/efspi/methods/methods_intro.html.

EFSPI's Annual Flagship Event

EFSPI's flagship event is the Regulatory Statistics Workshop, which has become a key platform for dialogue between the pharmaceutical industry, regulatory agencies, health technology assessment bodies, and academia. The workshop emphasizes collaboration and focuses on open dialogue on statistical and regulatory decision science. The next workshop is scheduled for the 10th to 12th of September 2025 at the Biozentrum in Basel, Switzerland, and it promises to uphold the tradition of excellence established by previous events. This year is particularly special as we celebrate the 10th anniversary of the workshop! We warmly invite all participants, whether joining in person or online, to be part of this landmark celebration. This event is not just an opportunity to reflect on the past decade's achievements but also a time to look forward with optimism to the future collaborations, interactions, and advancements that will shape our field.

For more information and to access materials from previous workshops, please visit the workshop website at https://efspieurope.github.io/workshop/next.html.

Embracing the Future

Looking ahead, EFSPI is focusing on business continuity, strengthening its strategic partnerships, enhancing its branding and visibility, and transforming into a federation that makes a difference today and into the future. Initiatives like the EFSPI Scientific and Training Academy, the NextGen movement, and engagement with key stakeholders such as the European Medicines Agency (EMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the American Statistical Association (ASA) are evidence of this forward-thinking approach.

With regards to EMA, just recently, EFSPI made contributions to the ACT EU Workshop on ICH E6 R3 at EMA in Amsterdam, which focused on the revised guidelines for Good Clinical Practice (GCP). EFSPI's involvement in this workshop underscores its commitment to ensuring that statisticians remain at the forefront of industry standards and practices. For those interested in exploring the workshop materials, including video recordings and slides, please visit the event page https://www.ema.europa.eu/en/events/act-eu-workshop-ich-e6-r3-principles-annex-1.

EFSPI actively participates in an industry focus group for future EU electronic submissions, known as the clinical data submission pilot. This EMA-led initiative, which includes an advisory industry group, aims to enhance data value in submissions. The focus group, with EFSPI holding three seats including the chair, works closely with EFPIA. The ongoing initiative has recently released an interim report which is available at https://www.gmp-compliance.org/gmp-news/interim-report-on-emas-clinical-study-data-proof-of-concept-pilot.

Another example is EFSPI’s recent letter, which expresses our support for efforts to advance open-source collaboration in statistical engineering and clinical reporting. We believe that cross-company collaborations, such as openstatsware (https://www.openstatsware.org/) and pharmaverse (https://pharmaverse.org/), offer unique opportunities to harmonize methodologies, standardize practices, and create accessible platforms for innovation in statistical analysis.

Conclusion

EFSPI's role in the pharmaceutical industry has become increasingly vital as it champions scientific excellence and adapts to the changing environment. Through the application of critical thinking and statistical knowledge, EFSPI not only aids existing professionals but also plays a pivotal role in developing future leaders and drug developers with a strong emphasis on statistics. As the industry evolves, EFSPI emerges as a pillar of knowledge, fostering collaboration and driving statistical innovation.

For more information on EFSPI's activities and resources, including previous workshops and webinars, please visit our website at www.efspi.org and follow EFSPI on LinkedIn (https://www.linkedin.com/company/efspi/).