Hamza - Data Analyst SAS

RESPONSIBILITIES
Ensuing data management activities coordination (Phase I/PKH)
Maaging subcontracted activities related to Paper CRF and eCRF studies
Specification Writing/review of technical documents (DVP, DRF, IA, Transfer Protocol, ...)
Performing quality control and validating database design
Managing ueries
Identifying and
recording non conformities
ACHIEVEMENTS
Phase 1 (PKH/CL1):
Conduct step of the study
S95010-Safety, tolerability
and pharmacokinetics after single escalating intravenous doses in young healthy male subjects. A randomised, double
-blind, placebo-controlled, monocentre, First-In-Human study.

SAS programmer at MCT CRO

RESPONSIBILITIES
Performng data manipulation, analysis and reporting of clinical trial data, both safety and efficacy;
Creating analysis files, tables, listings, and figures (TLFs), validating those files, maintaining
associated tracking and validation documentation;
Writing Medium to high complexity SAS programs and macros.
Deliver individual programming deliverables of
medium to high complexity within a single project.
Perform quality control in support of clinical trial activities.
ACHIEVEMENTS
Phase 3: Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor
–Positive, Human
Epidermal Growth Factor Receptor 2–
Negative Advanced Breast Cancer
Phase 2: Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001
Administered to Patients With Advanced Malignancies
Phase 1: Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL15/sIL-15Ra)) Alone
and in Combination With PDR001 in Adults With Metastatic Cancers
Phase 3 (pooled): 24-month Double
-blind, Randomized, Multicenter, Placebo
-controlled, Parallel
-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingo
limod (FTY720)
Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple
Sclerosis With Optional Extension Phase

SAS programmer at DatametrixCRO

RESPONSIBILITIES
Programming of the deliverables, i.e. datasets and TLFs (Tables, Listings and Figures).
Respecting all SOPs and BGs related to the tasks.
Ensure that updated templates are respected and all available information is accounted for Projects.
ACHIEVEMENTS
Phase 3:
A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 μg SOM230,
Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease
-Novartis
Phase 3: Multicenter Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild
-type (wt), Advanced Non
-small Cell Lung Cancer (NSCLC)-Novartis

Phase 4: A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group
Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypert
ension-Actelion

Phase 4: A Prospective, Multicenter, Single
-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by
Cardiac Magnetic Resonance Imaging

Efficacy and Tolerance Evaluation of an Anti -age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group–L’Oreal

RESPONSIBILITIES

Sample size determination

Assist in the implementation of protocol methodology and statistical analysis plans.

Analyze clinical trial and healthcare marketing data producing accurate results representing the
outcome of the trial or study, validate statistical output, accurately interpret and clearly communicate statistical results and concepts to non-statisticians.

Contribute to the design and direction of research projects.

ACHIEVEMENTS
Phase 3: A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of
Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Reson
ance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate -Roche

Epidemio-marketing study of the management of breast cancer patients in Tunisia -Roche

Phase 4: Multicenter, Prospective, Placebo-Controlled Study toAssess Efficacy of Meteoxane in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) in Patients Who Report Inadequate Control of IBS-D Symptoms –Alpha Wassermnn

Coordination and management of donation programs for patients with MULTI
PLE SCLEROSIS -Merck October
-December 2013: Census Supervisor at the National Institute of Statistics. Interships

engineering internship at the National Institute of Statistics: "Corrections of
seasonal variations (CVS) by the method x11-x12 ARIMA."Graduation Project at the Pasteur Institute in Tunis: "Survival Analysis and
healing factoring of zoonotic cutaneous infection leshminiasis in Center of Tunisia"

engineering internship at the National Institute of Statistics: "Corrections of
seasonal variations (CVS) by the method x11-x12 ARIMA."

Introductory internship in professional
life at the Public Health Ministry, "Effect of the revolution on the behavior of patients in the regional hospital of Metlaoui."
Professional training