Christine Cotton — Curriculum Vitae (English)

Source: https://christinecotton.com/CV_CCottonEng-v2.pdf (5 pages). Text extracted from her own English-language CV.

Founder and director of Statitec, a Contract Research Organization specialized in data management & biostatistics.

Participation in Data Safety Management Boards as an expert biostatistician
Participation in international trials and FDA submissions
Expert in clinical trial methodology
Quality assurance officer at her company
Biostatistician
SAS® programmer

Experience across all phases of clinical trials and numerous therapeutic areas: osteoarthritis, osteoporosis, diabetes, influenza, hepatitis C, tuberculosis, ovarian cancer, colorectal cancer, breast cancer, follicular lymphoma, lymphocytic leukemia, multiple myeloma, kidney transplantation, depression, cognitive disorders, Alzheimer’s disease, sinusitis, eczema, psoriasis, hemangioma, ulcerative colitis, Crohn’s disease, rheumatoid arthritis, chronic bronchitis, allergies, gout, hypertension, heart failure, menopause, incontinence, benign prostatic hyperplasia, impotence, child nutrition…

Personal

Birth date: 27 April 1970

Education

1993–1997 — Master’s degree (Magistère) of Economy and Statistics, Toulouse School of Economics / University Paul Sabatier (Toulouse)
1992–1993 — Bachelor of Sciences degree in econometrics, Toulouse School of Economics

Languages

French (mother tongue), English (good knowledge), Spanish (good knowledge)

Professional experience

2023 — Consultant for the pharmaceutical industry — clinical trials, observational studies: methodology, sample size, protocol writing, statistical analyses.

Since 2020 — Whistleblower. Author of an expert report on the Pfizer clinical trial for its COVID vaccine in relation to Good Clinical Practice, highlighting multiple methodological and statistical biases invalidating its efficacy and safety conclusions. Author of the book “Tous vaccinés, tous protégés? Vaccins Covid-19, chronique d’une catastrophe sanitaire annoncée”, with a preface by Senator Laurence Muller-Bronn, MEP Michèle Rivasi, MEP Virginie Joron and former MEP Martine Wonner.

2018–2019 — Freelance consultant for the pharmaceutical industry: protocol methodology, protocol writing, sample size, statistical analysis, compliance to pharmaceutical industry guidelines.

1995–2018 — CEO, Statitec (Clinical Research Organisation). Expert in Data Safety Management Board; Quality Assurance Officer (maintenance/update of SOPs, quality standards, protocol & CRF writing, scientific advice); Head of biometry (planning, supervision of data-managers and biostatisticians, statistical expertise, management of observational studies and ATUs/RTUs, validation of statistical activities); Biostatistician (randomization lists, sample-size calculation, Statistical Analysis Plans, SAS® programming, descriptive statistics, variance/covariance analysis, survival analysis, multivariate models, various designs, genomic studies; clinical study reports per ICH E3).

1995–1996 — Laboratoire Statistiques et Probabilités: biostatistician for Pierre Fabre laboratory; SAS® programmer.

1994–1995 — Translator (English to French) of the software manual “Data analysis with student Systat” — International Thomson Publishing France.

Technical skills

Systems: Windows XP/NT, SBS 2003/2008/2011
Languages: SAS® (base, macro, stat, graph…)
Software: Word, Excel, PowerPoint, Qualigram, NQuery, East, PASS, Capture System

Clients (selection)

Archimedes Pharma, AstraZeneca, Aventis, Bausch & Lomb, Bayer, Ceva, Danone, Debiopharm, Ferring, Forenap, Galderma, Ipsen, Janssen-Cilag, LPG System, Mayoli Spindler, Medtronic, Menarini, Merck Lipha Santé, Novagali Pharma, Novartis, Orfagen, Pherecydes Pharma, Roche, Pierre Fabre, Sanofi, Synthélabo, Servier, Takeda, Théa, Yamanouchi, hospitals, associations…

Selected publications / studies managed by Statitec

She is a named co-author on, or managed the data for, numerous peer-reviewed studies, including (with PubMed/DOI links in the original):

An 8-week, randomized controlled study of a 0.1% chlorhexidine mouthwash in chronic periodontitis (Tenenbaum H, … Cotton C, … J Investig Clin Dent. 2011). PMID 25427325
RealTrend study — continuous glucose monitoring when starting pump therapy in type 1 diabetes (Diabetes Care 2009). PMID 19767384
Pomalidomide + low-dose dexamethasone in multiple myeloma, IFM 2010-02 (Blood 2013). PMID 23319574
Lenalidomide maintenance after stem-cell transplantation for multiple myeloma (NEJM 2012). PMID 22571202
SAKOS study — titanium vertebral augmentation device vs balloon kyphoplasty (Spine J 2020). PMID 32927099
Hepatys French cohort — pegylated interferon-α2a + ribavirin for chronic hepatitis C (Antivir Ther 2012). PMID 22267474
Blood memory B cells and response to rituximab in rheumatoid arthritis (Arthritis Rheum 2011). PMID 22127692
Fentanyl pectin nasal spray for breakthrough cancer pain (Douleurs 2017)
Medication nonadherence after renal transplantation — French observational study (Transplantation 2013). PMID 23149477
ELIXIR study — capecitabine for advanced/metastatic breast cancer
Preservative-free hypertonic ophthalmic solution for corneal edema (J Fr Ophtalmol 2015). PMID 26443383
Characteristics and management of gout patients in Europe (Eur Rev Med Pharmacol Sci 2015). PMID 25753881
Gastric emptying evaluation by ultrasound prior to colonoscopy (World J Gastroenterol 2014). PMID 25309090
EDUPSO study — education programme in moderate-to-severe psoriasis (Dermatology 2022). PMID 34883480
PhagoBurn — phage therapy for burn wounds infected by Pseudomonas aeruginosa, the world’s first clinical trial on phagotherapy, Pherecydes Pharma, €5M subsidized (Lancet Infect Dis 2019). PMID 30292481

Temporary Authorizations / Recommendations for Use (ATU/RTU)

Management and statistical analysis of data for several ATUs and RTUs: relapsed/refractory mantle cell lymphoma or chronic lymphocytic leukaemia, metastatic prostate cancer, chronic hepatitis C genotype 1, HIV, multidrug-resistant pulmonary tuberculosis, non-IgM AL amyloidosis and Randall’s disease, active ulcerative colitis, Crohn’s disease, proliferative infantile haemangiomas.