Daniel Wanjiru Email and Phone Number

• Lead programming efforts for complex studies, collaborating directly with project team leaders and client representatives.• Conduct team meetings, develop project timelines, assess resources, and monitor study budgets.• Assume leadership within multidisciplinary project teams, ensuring adherence to standard operating procedures (SOPs).• Independently create, validate, and maintain data transfer programs across multiple systems using SAS.• Combine and store data from various sources, generate reports, and produce summaries.• Manage assignments to meet timelines and uphold high-quality standards, while adhering to contractual obligations.• Continuously enhance knowledge and professional skills in programming, technology, clinical trials, and the pharmaceutical industry.• Provide training, guidance, and project leadership to junior team members.• Offer general infrastructure support to the department, including representation at industry conferences and contribution to departmental documents and policies.• Provide input into the bidding process when requested.

• Develops and performs quality control on analysis datasets and tables, figures and listings via an appropriate statistical analysis system (i.e. SAS®).• Provides input to the statistical analysis plan, table shells, data integration plans, and publications.• Liaises with other departments to properly implement data models (e.g. SDTM/ADaM).• Researches new technologies and techniques to improve the efficiency of programming outputs.

• Develop and review SAS specifications, programs and output for the creation of ADaM and client-defined analysis datasets, tables, listings, and graphs in support of Statistical Analysis Plans• Assume team member responsibilities, including representing Statistical Programming at intimal project team meetings and with support from senior Statistical Programming staff at client meetings.• Demonstrate good problem-solving skills, a proactive approach and a willingness to make decisions, seeking advice from senior Statistical Programming staff to confirm decisions when necessary.• Understand the scope of the project in order to advise the Senior Statistical Programming Staff of changes in the scope of projects to enable the timely development of change orders.• Assist with training, mentoring of Statistical Programmers under the supervision of senior Statistical Programming staff.• Participate in the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study-related documentation.• Prioritize personal workload to meet specified completion dates.• Carry out all activities according to SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).• Perform other duties as assigned by Senior Statistical Programming staff.• Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs• Produce Data guide, Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviewers Guides to support SDTMs and ADaMs• With support from senior programming staff - develop specifications for SDTMs and ADaM datasets• Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff• Respond to QA and client audits with support from senior programming staff

• Created ADaM compliant Analysis Datasets with derived variables (including Vital Sign, Adverse Event, Medication) datasets respectively according to analysis datasets specifications and SAP (Statistical Analysis Plan).• Developed SAS programs for analysis datasets, based on the CDISC and/or client specific standards.• Developed SAS programs for study TFLs, based on study SAP and Shells.• Adhered to all relevant Standard Operating Procedures (SOPs), for all clinical programming relatedactivities.• Created plans and communicated deadlines effectively, to ensure projects were completed on time.• Prioritized quality in all activities undertaken, by ensuring the principles in the Company checklistare followed rigorously, and carefully performing self QC of own work.• Provided statistical programming and validation support for statistical tables, figures, listings.• Adapted to the client’s extensive macro system and mentored new programmers

• Generated, organized, and displayed complex statistical analysis using SAS, Rprogramming.• Collected and recorded data and coded data from source documents into excel sheets.• Performed data entry, data cleaning and analysis on large datasets with sample sizes ofover 350 and with over 20 attributes.• Applied advanced statistical technique for various existing and on-going research project.• Prepared the results of the statistical analysis in the form of charts, tables and graphs using efficientdocumentation procedures.

Responsibilities Maintaining a cordial working relationship with the school administration, teachers and the community. Maintaining an accurate record of the progress made by each reader using VGA Records Book. Providing relevant information and reports to the parents of the identified readers in consultation with the class teacher. Participating in all monitoring and reporting activities. Initiating and undertaking a community engagement project.

Responsibilities Maintaining a cordial working relationship with the school administration, teachers and the community. Maintaining an accurate record of the progress made by each reader using VGA Records Book. Providing relevant information and reports to the parents of the identified readers in consultation with the class teacher. Participating in all monitoring and reporting activities. Initiating and undertaking a community engagement project.