Sam Warden Email & Phone Number

Earls Barton, Gb

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Responsible, in collaboration with an awesome team, for the transformation and modernization of the Programming Function through the use of cutting edge methods, techniques & tools in alignment with R&D Strategies. Leading the strategy for skill transformation and capabilities in support of strong, agile decision making.

Accountable for the implementation of d-Wise global strategy across Europe and the contribution of European insights to that strategy. Delivering significant impact for our biopharmaceutical and healthcare clients in the field of clinical data science.

Leading a global team of consultants to simply deliver change in clinical data delivery for the life sciences sectorEngaged with a broad cross-section of big pharma and biotech and CROs to identify opportunities to improve and enhance their clinical data processes and technologies and then to deliver them pragmatically and effectivelyGrowing d-Wise in Europe and beyond

Geneva, Ch

Founding organisation: Expanding Your Horizons ("Elargis tes Horizons " in French). Created in 1974 in California by women scientists who believed young girls had the same aptitude but less opportunities in STEM careers.Each year EYH organises over 100 conferences in the States and other countries, bringing together 25,000 young girls – nearly a million since its creation.Expanding Your Horizons arrived in Europe in 2009 – with the first conference taking place in Geneva with 250 girls. It was successfully repeated in 2011 and 2013 with the support of the State of Geneva and University of Geneva.I have been involved as a workshop leader since 2009 and this year have taken on a role as Treasurer. The organization in Geneva is in a very interesting phase as it aims to expand its reach and provide a more sustained offering to girls throughout the year

Princeton, New Jersey, Us

Responsible for a global organization of 300+ staff delivering on-time on target laboratory data to investigators and sponsors. Data which comprises a significant proportion of all data submitted for New Drug Applications across the world.Accountable for an annual budget of over $20 millionMember of executive leadership team driving strategic decisions to sustain a “leading the market” positionSponsorship of client relationships and internal change projectsDeveloping and promoting talent globallyChampioning operational excellence to maintain efficient processes which deliver high quality data

Darmstadt, Hessen, De

Set up and led global team of change agents and service providers which achieved:•Simplified processes which operate globally and cross-functionally•Standards for analysis data and statistical output which are supported by statistical tools enabling greater efficiency and productivity within the department•Proposals for innovative in trial designs and analysis which could reduce the sample size and duration of trials conducted (presented at conferences by team members)•Selection of a CDISC compliant repository for clinical data•Partnership with offshore functional service for programming and statistical analysis as an extension of the in-house team reducing the costs of trial analysis and reporting

Consulting to bring technology and process change consultancy, coaching and mentoring to individuals, teams and organisations. Providing a practical approach to deliver change fast throughout an organisation. Exploiting processes and technology to transform businesses.

Boston, Massachusetts, Us

Responsible for the provision of statistical programming of clinical trials data for Geneva-based trials, and the development of standard global applications for analysis and reporting. Main achievements have included:• Delivery of a business change project to implement a standard tool for analysis and reporting worldwide • Developed a group into a team who consistently deliver and work to global standards• Increased the influence of the group demonstrated through increased demand for involvement and consultancy• Manage activities for clinical trials, marketing and publications in the following therapeutic areas:• Dermatology• Reproductive Health• Metabolic Endocrinology• OncologyResponsibilities include consistently reliable forecasting of resources and managing of budgets to achieve smooth support for clinical trials, marketing and publications. Provision of strategic input to departmental and cross departmental operations.

Brentford, Middlesex, Gb

Responsible for the provision (full development lifecycle) of standard technology and processes globally for the analysis and reporting of pharmaceutical data (throughout R&D). Main achievements have included:• Recruitment, set-up and development of a new, highly motivated and functional team following the merger• Successful proposal (corporate board level) & project set up for the harmonisation and improvement of the business processes and technology supporting it. This project provided productivity gains and regulatory risk reduction in excess of £8 million per annum. I was actively engaged in the management of key stakeholders for projects via regular meetings, presentations, attendance at management team meetings and strategic review. Other projects managed by my group included the strategy for Electronic Data Capture, Inclusion of documents into the Regulatory Document Management System and setting up the process for the management of SOPs and Working Instructions.

Brentford, Middlesex, Gb

Co-ordination of 15 statisticians and programmers to provide the analysis of anti-microbial clinical trial submission data in support of successful new drug applications and product line extensions in the US and Europe. Track record of delivering study and submissions ahead of schedule. Represented department on cross-functional submission teams.Business leader for process and technology change initiatives relating to improved automation of clinical study report collaborative authoring. This project included team members from Clinical Research, Biomedical Data Sciences, Medical Writing, Clinical Safety and Regulatory Affairs.

Brentford, Middlesex, Gb

Provided business analysis in support of high profile submissions for high level IT management team. Ensured that bottlenecks or obstacles in processes were removed or enabled with technology. Led technology and process change projects in the area of collaborative computing, submission printing, Lotus Notes backup provision and capacity planning. Contributed to significant reductions in cycle time for 3 major drug submissions (Metabolism, Neurology and AntiInfective therapy areas).

Brentford, Middlesex, Gb

Led the identification, evaluation and implementation of a desktop statistical analysis package for research and development scientists (all therapy areas, from early research, Medicinal Chemistry and Toxicology to Pharmaceutical Technologies) . Performed analysis, engineering and training roles for the selected product. Also supported statistical computing requirements of a team of 20 statisticians located in the UK and US.

Trained from graduate recruit in Clinical Data Management for a small (30) department to become responsible for the recruitment and management of a team of 7 programmers to provide study data analysis for customer organisations as part of a 250-strong department. Managed contracts and customer liaison for a number of studies providing cost estimates and brokering changes in requirements as needed throughout the contract lifecycle. Ensured programming line needs were met in terms of training and staff development. Instrumental in process revision and redesign as the company grew over the years.

Data Science For Managers Bootcamp, Data Science

Mba, Business Administration And Management, General

Bsc, Biology

Education record