Miguel Fernandez-Santos

My current job as contractor for IQVIA Biotech (Formerly known as Novella) focuses on small-medium biotech firms which outsource all biostatistic and CRO resources to IQVIA, hence, as part of a team, I deal with:

• Drafting and validating TFL shells, CDISC-ADaM specs and other analysis datasets when required and following sponsor and Company's standards.
• Writing Statistical Analysis Plans (SAPs), signing off forms 872 once amendment was approved.
• Dealing with estimands analysis and reporting when required and defined both by Protocol and SAPs.
• Advising DMCs and supporting with DSUR analysis when required. DSMBs and DMCs when required; by abiding to SOPs and guidelines by Company.
• Monitored clinical trials or experiments to verify adherence to established procedures and quality of data collected.
• Developed and MMRM mathematical models to deal with missing data and, when required.
• Contributed to proposal and budget development by developing funding applications and research protocols.
• Calculated sample size requirements for clinical studies.
• Drew conclusions and made predictions based on data summaries or statistical analysis.

Clients I am working with: Decibel Therapeutics, Wugen Inc (CAR-T Cell Inhibitor), Immunocell Therapeutics, and some others; all small-medium size firms.

Principal biostatistician for phase I and Ib (PK/PD) trials of VPM087 (gevokizumab), modelling from datasets and Bayesian feedback analysis

• Develop statistical methods sections of protocols and review case report forms (CRFs).
• Prepare analysis plans and write specifications for analysis files, tables, and figures.
• Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.
• Interpret analyses and write statistical sections of study reports.
• Provide training, guidance and mentorship to lower level and new staff.

As contractor, either inside or outside IR35 with several CROs an sponsors, amongst, but not limited to, my duties and projects were:

• Coordinate t development of analysis plans, table shells, programming and table specifications, production of tables, listings and figures, data review and statistical analysis.
• Perform protocol development, sample size calculation, protocol and CRF review.
• Advise data management staff on database design, and critical data. May advise on validation checks.
• Write statistical sections of integrated reports.
• Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
• Act as statistical team lead for single complex studies or groups of studies.
• Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.
• Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.
• Manage customer relationships.
• Provide training and guidance to lower level and new staff.
• Involved from the phase I and II up to latest stage. Holding SOPs, whilst, supporting M&S analysis plans and reports, always abiding to the existing SOPs and policies. Modelling PK/PD from datasets (using SAS , NONMEN and S- PLUS). Working with the Outcomes Research department as supplier of output data from SAS (CDISC and RAVE).

As key projects:

• Astra Zeneca: Lead Statistician within Oncology Area (Contractor by a CRO); main trials à DESTINY- Breast02 and DESTINY-Breast03 trials with Enhertu® (Trastuzumab deruxtecan) in patients with HER2- positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.
• Novartis Group: Principal biostatistician for Kesympta® (Ofatumumab) Trials (ASCLEPIOS I and II) in Relapse/Remitting Multiple Sclerosis.
• Abbott: Senior biostatistician responsible to support submissions of diabetes new line of products (
• Novartis Group: Onco-hematology trial, phase III and IV (Kymriah®), and phase IV of KISQALI® - undergoing), for submissions to EMA and FDA
• Chugai Pharma: Phase III ® trial (ADMYRE), in Multiple Mieloma: working with SAS scripts to ensure consistency with CDISC standards on the Oncology semantic.
• Jansen Cilag : Phase I and II of Imbruvica® in Chronic Lymphocytic Leukaemia. Involved from the phase I and II up to latest stage.
• Janssen Cilag: SAR3007 trial Trabectedin vs. Dacarbazine on Advanced Soft Tissue Sarcoma Treatment, phase III Trial). Datasets generation and analysis.
• Onyx Pharmaceuticals (now Amgen) · Carfilzomib (Multiple Myeloma)
• Viropharma (now Takeda) Marivabir, phase II trial (Viropharma) -PK/PD models too-.
• Janssen Cilag: Daratumumab monotherapy (Relapsed / Refractory Multiple Myeloma), phase I (GEN501 trial). GENMAB and J&J, writing the SAP, SOPs and working with nearly all SDTM 3.1 domains, but namely with LB, AE, QS, TU, TR (PROC CDISC) PC, PK, and biomarkers. (2014-2016)

• Senior Biostatistician in the areas of Opthalmology and CNS:
• Amongst my duties:
• Programming SAS procedures and macros to execute ADaM and SDTM specs. Dry-runs.
• Monitored clinical trials or experiments to verify adherence to established procedures and quality of data collected.
• Drew conclusions and made predictions based on data summaries or statistical analysis.
• Calculated sample size requirements for clinical studies.
• Examples of work:

o PREEMPT I and II → Botox(R) use as pre-emptive treatment in patients -without medication overuse previous history- with Chronic Migraine. SAS analyst in the pre-clinical and clinical studies.

o GENEVA Study: Use of Ozurdex(R) as intra-vitreal implant in patients with BRVO or CRVO. Randomised Control Trial vs. Sham. SAP responsible and CRF writer. (phase I and II)

• SAS programmer in clinical trials ensuring CDISC compliance
• Collating and treating Clinical Data from Sites (outcomes) and reporting Adverse Effects and Serious Adverse Effects to the Spanish Agency and the Headquarters.

• Conducted research to test and analyze feasibility, design, operation and performance of equipment, components, and systems.
• Read and interpreted blueprints, technical drawings, schematics, and computer-generated reports.
• Illustrated potential obstacles when conducting site assessments for planned projects.
• Resolved architecture, design or verification problems by applying sound ASIC engineering practices.

• Chromatography and Spectrometry areas:
• Read and interpreted blueprints, technical drawings, schematics, and computer-generated reports.
• Routed and integrated technical and electrical components for projects.
• Participated in formal internal design reviews of proposed products and components.