Greater Cambridge Area
Group Leader, Lead Statistician, Expert Programmer, Data Manager and Evidence Generator with over 25 years’ experience of drug development in the pharmaceutical and biotechnology industry; wide-ranging knowledge of interventional clinical trials and real-world evidence generation (retrospective and prospective observational studies and secondary data sources) and a keen interest in innovative methodology, SAS/R/Python programming, patient engagement and patient centricity.
Global responsibility for all pre- and post-approval Statistical, Programming, Data Management and HEOR activities across Mundipharma Research and Development primarily in drug development with involvement into consumer health, medical affairs and systems development. Including delivery of clinical studies (TFLs), Integrated analyses (ISE/ISS) and output for HTA submissions. Lead Statistician and programmer across multiple areas including Oncology, anti-fungal therapies, Pain Management, and Biosimilars reporting directly to the VP, R&D. Providing guidance and direct input into strategy, planning and contents of clinical development plans and regulatory submissions. Interaction with key global regulatory authorities, key stakeholders and vendors to develop and maintain applications for Orphan Drug Designations (ODD), Promising Innovative Medicine (PIM), Early Access to Medicines Scheme (EAMS) and Marketing Authorisation Applications. Presenting key results and proposed indications at EMA Rapporteur/Co-Rapporteur meetings as well as attendance at MHRA, FDA and ANVISA meetings, and leading response to statistical questions. Manage a small group of Statisticians, Programmers, Data Managers, Data Scientists and Health Economists with varying degrees of experience, development needs and diverse cultures. Primary contact for statistical discussions with key alliance partners and due diligence activities. Manage multiple vendors including transfer of services when required (rescue), RfPs, Scope Changes and Budget management. Vendors include global players as well as more niche organisations. Global responsibility for maintaining Mundipharma’s Life Science Analytical Framework (LSAF) partnered with SAS. Expertise in SAS programming.
Line-manage, mentor and develop a diverse group of Statisticians and RWE Scientists across all therapeutic areas and time-zones, delivering Real World Evidence studies including prospective and retrospective observational studies, enriched designs and analysis of secondary data sources. Manage the delivery of projects via hands-on role, mentoring, scope discussions & resolution and through senior level review. Accountable for resource and budget management. Define and recruit to roles, expanding the offerings within IQVIA Scientific Services aligned with both Global and Regional needs to include enriched studies, extension studies, pragmatic clinical trials, and secondary data use. Expand the global footprint of the Biostatistics group (resource and budget control) within IQVIA’s Scientific Services group to support the Regional Business Units in Europe and Asia-Pacific regions. Provided strategic statistical input into IQVIA RWE business development aligned with Client’s RfPs, Scope of Work (including identification of out-of-scope variations) and Bid Defence Meetings including pricing and budget planning.
Global Lead Statistician for Diabetes, Obesity and Alzheimer’s Development Programs and European Therapeutic Area Lead Statistician for Cardiovascular, Neuroscience, Metabolic, Bone Health, Inflammation and Nephrology. Provide strategic input into the clinical development plans for Global Development Programs to align with the Target Product Profiles. Led a global team of statisticians and programmers working with collaborators and Functional Service Providers to deliver innovative designs and high-quality studies and analyses. Manage performance, oversee deliverables, mentor and develop the careers of a team of 10-12 statisticians (on-site and remote, graduate to 20+ years’ experience) operating on diverse areas of medical research from Early Development (FIH), through Phases 2, 3 and 4, Integrated Summaries, RWE, Health Technology Assessments (NICE, AMNOG, etc,) in cardiovascular disease, diabetes, bone health, anaemia, secondary hyperparathyroidism, migraine, hypercholesterolemia and psoriasis. Experienced SAS (SAS/STAT, SAS Graph and SAS Macro) programmer. Knowledge of CDISC (SDTM and ADaM), CDASH and Tables, Figures and Listings (TFL) standardisation. Lead statistician for Therapeutic Area related publication approvals (Abstracts, Manuscripts and Posters) within the EU region to assess statistical rigour. Led or participated in developing Amgen’s Global guidance on Intent-to-Treat principles, Considerations for Missing Data and Quality Control of Statistical Programs. Delivered and led the statistical training activities for non-statisticians in Europe and developed global training modules for communicating statistics to patients and HCPs. Led a cross-functional team to standardise Amgen’s TFL deliverables; KPI to have 80% standard to aid transfer of knowledge and reduce resource burden.