Jessica Schohn
Sélestat
Summary
I am Principal Statistical Programmer on a team and bring over 20 years of relevant experience within the pharmaceutical environment from both CRO and Pharma, mainly in Oncology and MS clinical trials on phases II and III studies. Responsibilities include the creation/validation of programs generating the derived datasets closely to specifications and internal/CDISC standards and the delivery of statistical outputs provided for clinical study reports.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Principal Statistical Programmer, PBS
Cytel Inc.
07.2024 - Current
- Deliver exemplary performance and solving complex technical program to inspire other programmers (standard macro templates), supported with detailed documentation.
- Ensure to be accountable for the quality, traceability, reproducibility and timelines of statistical programming deliverables.
- 6 months dedicated as support programmer on a MS study conducted in R programming.
- Support a whole Phase 1 study for PMDA submission: SDTM mapping, ADaM datasets and Pinnacle 21 report, ADaM define, ADaM reviewer’s guide, tables and listings draft and final.
Senior Statistical Programmer, PBS
Cytel Inc.
03.2018 - 06.2024
- Full 5 years dedicated as project programmer on ISS project: deliverables for PMDA, China, EMA and FDA submissions with additional requests to be answered in very short timelines (together with the maintenance of the in-house database), BIMO deliverables for FDA NDA filing, Sensitivity Analysis related to Covid-19 and Ukraine Crisis, CRO surveillance, Oversight task, DSUR/PBREL, while developing a huge collaboration with the client.
- Lead, or contribute to, statistical programming activities on PBS projects (development or QC of deliverables).
- Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements.
- Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…).
- Understand, follow and ensure adherence to all PBS SOP as well as any other relevant SOPs.
- Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation.
Senior Statistical Programmer
Novartis
03.2013 - 02.2018
- Working as a Senior Statistical Programmer on phases II/III studies in the Oncology area, responsible for the below tasks:
- Lead a global programming team:
- Conduct programming activities: development of specifications for derived datasets following internal & regulatory guidelines. Development and validation of derived datasets, development and validation of deliverables including Health Authorities questions (Tables/Figures/Listings) with SAS software.
- Coordinate programming activities.
- Ensure internal and regulatory guidelines are properly implemented.
- Bring necessary support in order to meet timelines.
- Ensure quality of outputs and results.
- Work closely together with clinicians, data managers, statisticians and medical writers.
- Determine resource projections and project schedules with functional management guidance.
- Lead the Safety Pool activities (studies completed and ongoing going through submission processes):
- RMP (Safety Risk Management Plan) - high level strategic document which describes important safety concerns on how to characterize further the safety profile.
- PSUR (Periodic Safety Update Report) - analysis of new or emerging information on the risks of the medicinal product.
- DSUR (Development Safety Update Report) - annual review and evaluation of pertinent safety information collected during the reporting period.
- CRS (Case Retrieval Strategy) process development and validation - reference document for specific definition of all safety topics being investigated during clinical development.
- Requirement for Japan submission.
- Exploratory Pooled Amenorrhea analysis to explore the incidence of female fertility events in patients on long-term drug treatment.
- Act as an Independent Programmer on a blinded study:
- Extract blinded and unblinded domains from Oracle platform to Global Programming and Statistical environment.
- Ensure all domains are correctly imported and work closely with platform expert to set up properly the transfers.
- Run programs defined by trial programmer in the restricted area and ensure log files are free of major errors/warnings and run as expected.
- Work closely with the trial programmer without compromising the blinding (“scrambling”).
- Lead a CDISC Phase II study:
- Review the protocol and Statistical Analysis Plan.
- Extract all domains from Oracle platform to Global Programming and Statistical environment.
- Set-up the whole NCDS process and a complete document for support.
- Act as a mentor for unexperienced NCDS/CDISC people.
- Develop the TDM/SDTM+/ADAM as per CDISC compliance.
Statistical Programmer
Aptiv Solutions
02.2012 - 02.2013
- Working as a Statistical Programmer on phase I studies in the Oncology area, responsible for the below tasks:
- Create and validate tables, listings, figures, and datasets according to the Statistical Analysis Plan to support the analysis of clinical trials data with advanced knowledge of statistical computing applications such as CDISC (SDTM and ADAM).
- Work closely with biostatisticians to establish analysis datasets and programming specifications for this output.
- Review reports for consistency between text and tables.
- Identify inconsistencies or problems in the database and reports findings to the appropriate department.
- Performs billable work in accordance with company policies, procedures and standard operating procedures (SOPs).
- Write documents and performs quality control of programs.
- Serve as a resource for, and interacts with, other functional areas to facilitate project timelines.
Statistical Programmer (contract)
F. Hoffmann – La Roche LTD
07.2005 - 12.2010
- Working as a Statistical Programmer on phases I/II/III studies in the Oncology area, responsible for the below tasks:
- Deliver projects to budget and time constraints.
- Interact with outsourcing partners (CRO, offshoring).
- Write, test and validate programs producing analysis datasets (VAD) and reports (listings, tables, graphs) for inclusion within CSRs and other publications, working to formal SOPs, Data Reporting and Analysis Manual (DRAM) and Protocol.
- Check programs written by another programmer (double programming).
- Pre-process programs required for creation of User Defined Listings.
- Review compiled SAS code against original requirements.
- Compare SAS code to specifications which have been written to verify they are fit for purpose.
- Understand and execute department-level, study-level and program-level macros and utilities.
- Write, test and validate study-level and program-level macros and utilities.
- Map Generic Data Model (GDM) dataset (specifications and programming).
- Create Data Quality Checks (DQC).
- Create appropriate Pre-Release Checks (PRC) for Report Objects of high Risk Reporting Events.
- Participate to requirements documents
- Main and extension phases CRF annotations
- Data Delivery Specifications and Programming specifications
- Quality Plan ensuring quality expectations and outcomes are identified.
- Work on User Acceptance Test: test patient CRFs are created and compared to the GDM data extraction programmed by Data Management.
- Specific projects:
- Pool project request to evaluate the incidence of symptomatic Congestive Heart Failure
- Cardiac rhythm disorders and LVEF drops, using the data from 6 Roche Herceptin trials
- Tail End Reporting on 3 Roche Herceptin trials to report all added, deleted or changed data collected between the last full reporting of a study and the freeze of the clinical database.
Statistical Programmer (contract)
Serono
06.2004 - 06.2005
- Working as a Statistical Programmer on phases I/II/IV Clinical Trials with complex designs in the New Therapy/Dermatology areas, responsible for the below tasks:
- Create listings, summary tables and graphs according to the Protocol and the Statistical Analysis Plan.
- Validate activities by double programming.
- Detail comparison between studies in preparation of a pool database.
- Give input on Case Report Form conception.
- Support Safety Review Boards.
Statistical Programmer/ Statistician
GEVES/ INRA
04.2003 - 04.2004
- As a first experience ending my studies, working on statistical analyses and plant variety evaluation with the help of the biometricians of the BIA unit.
- Homogenize the whole available database collected by GEVES on the national trials system from 1997 to 2002.
- Design mixed-effects models to structure the genotype×environment interaction, explore the genotype performances (using SAS GLM and SAS MIXED procedures) and evaluate the contribution of a tolerance gene to the pyralis, the main ravager of maize fields in France.
- Create a document on the statistical methods to adopt (linear mixed-effects models) for modelling, building and design of dimensional models to adjust effective of oaks forks and epicormic branches (using SAS GLM and SAS MIXED procedures).
Education
Master of Science - Statistics and Digital Methods
University of Marne La Vallée
Master of Science - Mathematical Engineering
University Louis Pasteur
Master of Science - Pure Mathematics
University Louis Pasteur
Bachelor of Science - Mathematics
University Louis Pasteur
Associates Degree - Mathematics & Economics
University Louis Pasteur
Skills
- Motivated and committed
- Good communicator
- Proactive
- Ability to work within a cross-functional team environment
- Experienced in managing workloads effectively, meeting deadlines and checking quality of own work
Certification
SAS Certificate Programming for SAS 9, at Novartis
Programming certifications (Amadeus trainings):
- Advanced SAS programming
- Advanced ODS Graphics
- SAS macros
Statistical certifications (“Excellence through Education” trainings on Statistics for Non-Statisticians Program):
- Module 2 – Study Design
- Module 3 – Survival Analysis
- Module 4 – Interim Analyses
- Module 5 – Oncology Endpoints & Statistical Issues
LANGUAGES
French: Mother tongue
English: Fluent-Speak, Read and Write
German: Basic-Speak, Read and Write
Awards
- Brevet National de Sécurité et de Sauvetage Aquatique (BNSSA) – 2001
- Attestation Fédérale aux Premiers Secours (AFPS) - 1997
- Clear driving licence - 1997
Hobbies
- Swimming
- Trail UTMB & Swimrun Ottilo
- Taking care of my 3 angels
Timeline
Principal Statistical Programmer, PBS
Cytel Inc.
07.2024 - Current
Senior Statistical Programmer, PBS
Cytel Inc.
03.2018 - 06.2024
Senior Statistical Programmer
Novartis
03.2013 - 02.2018
Statistical Programmer
Aptiv Solutions
02.2012 - 02.2013
Statistical Programmer (contract)
F. Hoffmann – La Roche LTD
07.2005 - 12.2010
Statistical Programmer (contract)
Serono
06.2004 - 06.2005
Statistical Programmer/ Statistician
GEVES/ INRA
04.2003 - 04.2004
Master of Science - Mathematical Engineering
University Louis Pasteur
Master of Science - Pure Mathematics
University Louis Pasteur
Bachelor of Science - Mathematics
University Louis Pasteur
Associates Degree - Mathematics & Economics
University Louis Pasteur
Master of Science - Statistics and Digital Methods
University of Marne La Vallée
Similar Profiles
Varuna AsthaVaruna Astha
Senior Biostatistician at Cytel Inc.Senior Biostatistician at Cytel Inc.
Prashant KamblePrashant Kamble
Pricipal Information Security Engineer at CytelPricipal Information Security Engineer at Cytel
Siva Sravani PonukupatiSiva Sravani Ponukupati
SAS Programmer Intern at Cytel Statistical Software and ServicesSAS Programmer Intern at Cytel Statistical Software and Services
FATIH SARACFATIH SARAC
Agent logistique at SHCMIDT GROUPEAgent logistique at SHCMIDT GROUPE
Anne-Sophie PatoutAnne-Sophie Patout
Aide-soignante en EHPAD at GHSOAide-soignante en EHPAD at GHSO