Mary Lekealem
Groveport,USA
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Statistical Programmer
Labcorp Drug Development
Toronto, Canada
02.2022 - Current
- Provide programming support for studies including Phase III Oncology (Breast cancer), Phase I-III Hematology (Anemia secondary to renal disease), and Phase I/II Infectious Disease (Bacterial Disease Therapy)
- Design program specifications based on consultations with Biostatisticians
- Generate SDTM and ADaM datasets (including TU, TR, RS, ADTTE, ADRS) as per the implementation guide and SAP using SAS SQL, SAS Macro Facility, SAS Graphics and R
- Create statistical analysis outputs to be used in support of final reports, manuscripts, abstracts, posters, ad hoc reports, and other clinical publications
- Write programs for integrated summary of safety/efficacy (ISS and ISE) and pooled datasets
- Draft QC programs for datasets, TFLs following departmental QC procedures and good programming practices
- Develop, evaluate, and validate utility programs and standardized macros
- Revise programs for corrections, enhancements, or action needed to rectify errors and warnings
- Ensure regulatory requirements are met through validation/compliance activities
- Generate Pinnacle 21 reports, Define XML, and reviewer guides
- Use and promote use of established standards, SOP, and best practices.
Lead Statistical Programmer
Altasciences CRO
Montreal, Canada
01.2018 - 01.2022
- Developed high quality programming to support sponsors’ research programs
- Supported Phase I/II Bioequivalence and Bioavailability studies and Phase I/II Psychiatry (Anxiety, depression) studies
- Served as Lead Statistical Programmer for assigned innovator projects
- Programmed SDTM/ADaM datasets (including PC, PP, ADPC, ADPP) for PK/PD analysis, and TFLs using SAS SQL, SAS Macro Facility, and SAS Graphics
- Performed quality control (QC) review and documentation of external datasets and programs used in creating statistical outputs
- Programmed datasets as per the implementation guide and SAP for Clinical Study Reports (CSRs), ISS, and ISE
- Provided final deliverables in accordance with CDISC for studies included in FDA submissions
- Programmed outputs to represent the statistical analysis plan (SAP) and raw data
- Performed peer review to ensure programming accurately reflected raw data and population flags
- Used efficient programming techniques to produce and/or QC TFLs (mean, median, geometric mean, coefficient of determination) with clinical endpoints Cmax, Tmax, AUC, Lambda, etc
- Followed SDTM standards and ADaM Implementations Guides for programming
- Collaborated with Lead Biostatistician to ensure programming outputs represented the statistical analysis plan (SAP) and raw data
- Contributed to dataset specifications, programming plans, and table shells
- Provided technical support and SAS advice to internal and external business partners
- Participated in kickoff meetings for various studies
- Maintained all supporting documentation for studies in accordance with SOP/Guidelines to ensure traceability and regulatory compliance
- Created Define.xml file (CRT- Case Report Tabulation) as per sponsor’s requirements
- Used P21 to validate data sets, ensuring they are CDISC compliant and error free.
Clinical Research Coordinator
Baptist Research Institute
Yaoundé, Cameroon
01.2015 - 01.2016
- Developed study tools and guides
- Trained clinical sites on data collection
- Interacted with field monitors to ensure appropriate management of study issues
- Coordinated activities at investigational sites
- Conducted co-monitoring visits and reviewed monitoring trip reports
- Assisted in the development of study timelines and priorities
- Served as the primary clinical liaison
- Prepared trial related documentation including protocols and case report forms.
Education
MSc. in Biostatistics -
University of Hasselt
01.2022
BSc. in Life Sciences -
University of Buea
01.2015
Skills
- SAS Certified Professional with MS in Statistics and 5 years supporting clinical trials
- Therapeutic Areas include Oncology, Cardiovascular, Infectious Disease, Hematology, Psychiatry
- Extensive knowledge and application of CDISC implementation guides for regulatory submission including SDTM, ADaM and preparing Definexml
- Excellent skills in SQL, SAS Macro Facility, SAS/GRAPH, SAS/STAT/SPSS, and R Strong experience in database setup, CRF review, EDC, and reviewing mock-up tables and program outputs based on TLF specifications
- Experienced in planning and statistical analyses of clinical trial data including PK/PD and review of clinical study reports (CSR) Experienced in reviewing clinical databases in accordance with Clinical Data Acquisition Standards (CDASH) to meet Biostatistician’s needs
- Lead projects, respond to QA, client audits, and support qualification audits
- Thorough understanding of regulation guidance and statistical methodology as applied to pharmaceutical development
- Excellent interpersonal and communication skills with good team player attitude
- Fluent in English and French
Certification
- SAS Certified Professional Advanced Programming (SAS 9.4), 12/2020
- SAS Certified Statistical Business Analyst (SAS 9), Regression and Modeling, 10/2019
- SAS Certified Specialist Base Programming Using SAS 9.4, 08/2019
Publications
Prediction of Obesity among Belgian Patients on CEN555. A phase IIb double blinded, single Centre parallel Dose finding trial, Nadege A. et al., 2018, Agoralaan Library, Diepenbeek. Hasselt, Belgium
Timeline
Senior Statistical Programmer
Labcorp Drug Development
02.2022 - Current
Lead Statistical Programmer
Altasciences CRO
01.2018 - 01.2022
Clinical Research Coordinator
Baptist Research Institute
01.2015 - 01.2016
MSc. in Biostatistics -
University of Hasselt
BSc. in Life Sciences -
University of Buea
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