Federico Rotolo
Senior Statistical Project Leader | Oncology
Salary / Daily rate
Marseille, France
Freelance, open to permanent contract
Remote only
Skills
Languages
About me
Intro
Senior Statistical Leader with 12+ years of expertise in oncology, biotech, and clinical research. Proven track record in driving FDA Fast-Track Designations and managing pivotal trials, with 31 peer-reviewed publications. Offering deep expertise in biomarker analysis, survival statistics, and clinical development to optimize your drug development programs and clinical trials.
Work experience
Sanofi
Feb 2022 - Present
4 years 9 months
Remote, OR 97458, USA
Statistical Project Leader, Oncology
Feb 2025 - Present
1 year 9 months
Remote, OR 97458, USA
Leading early-stage oncology projects, with both in-house studies and in collaboration with other pharma companies. Contributing to the design of new trials, the protocol set-up, the definition of the TPP, the long-term / late-phase strategy, the CDP, the go/no-go criteria, the planning of activities and resources to secure milestone achievement, the oversight of study-level statisticians.
Statistical Project Leader, Biomarkers
Oct 2023 - Jan 2025
1 year 4 months
Remote, OR 97458, USA
Skills: Clinical Development · Mentoring · Normes CDISC · Biomarkers · Git · Good Clinical Practice (GCP) · Oncology · Pharmaceutical Companies · Sociétés de recherche sous contrat (SRC) · Drug Development
Associate Statistical Project Leader, Oncology Early Phase and Biomarkers
Feb 2022 - Oct 2023
1 year 9 months
Remote, OR 97458, USA
In charge of biomarker statistical activities for four oncology trials. Implemented a joint modelling with biological activity and safety for dose selection in oncology phase-1 trials.
Sr Statistician
IT&M STATS
Jul 2021 - Jan 2022
7 months
France · Remote
Biomarker Statistician in Oncology on behalf of Sanofi
Innate Pharma
May 2018 - Jul 2021
3 years 3 months
Hybrid
Senior Manager of Biostatistics and Data Management
Feb 2020 - Jul 2021
1 year 6 months
Hybrid
Statistical support to successful applications for FDA Fast-Track Designation (FTD) and EMA PRIME for lacutamab. Participation in MAA submission in Europe for moxetumomab pasudotox-tdfk
Manager of Biostatistics and Data Management
May 2018 - Jan 2020
1 year 9 months
Hybrid
Set-up of a Biometrics Unit from scratch Design and conduct of a pivotal trial
Researcher in Biostatistics Methodology
INSERM (U1018 CESP, OncoStat Team)
Feb 2015 - May 2018
3 years 4 months
94800 Villejuif, France
Research on methods for: validation of surrogate endpoints, development and validation of genomic signatures, multi-state models, frailty models, copula models, simulation studies. Co-supervision of PhD students (3) and MSc students (3)
Biostatistician
Institut Gustave Roussy
Feb 2013 - May 2018
5 years 4 months
94800 Villejuif, France
Clinical Trials, meta-analyses, validation of surrogate endpoints... Member of the Scientific Board for clinical trials sponsored by the Gustave Roussy hospital. Organizing with E Lanoy the research seminars of the Biostatistics Unit
PhD Student
University of Padova
Feb 2010 - Jan 2013
3 years
Padova, Italy · Hybrid
Research on Frailty Models and Multi-State Models under the supervision of Prof. M. Chiogna and Prof. C. Legrand
Visiting PhD Student
Université Catholique de Louvain
Feb 2011 - Dec 2012
1 year 11 months
Ottignies-Louvain-la-Neuve, Belgium
Research project on Frailty Models and Multi-State models with Prof. C. Legrand, Prof. I. Van Keilegom and M. Munda
Trainee Biostatistician
E.O. Ospedali Galliera
May 2007 - Aug 2007
4 months
Genoa, Metropolitan City of Genoa, Italy
Clinical data analysis in Radiotherapy
Education
Università degli Studi di Padova
PhD
2010 - 2013
3 years 2 months
Università degli Studi di Padova
MSc
2007 - 2009
2 years 2 months
Université Côte d'Azur
L3 STID
2007 - 2007
2 months
Università degli Studi di Genova
BSc
2004 - 2007
3 years 2 months
Licenses & certifications
Verified Peer Reviewer
Issued: May 2025
SAS Programming for R Users
Issued: Apr 2019
Reproducible Research
Issued: Sep 2014
SAS Certified Base Programmer for SAS 9 (CBP)
Issued: Feb 2012