John Gaitho Email & Phone Number

• Develop, review, document and perform validation of SAS programs and macros.• Support the development of data repositories, pooling multiple studies• Create standard reports in different output formats• Automate programming tasks within the SAS environment• Generate programmed QC checks• Build utilities in support of other programming tasks• Design new tools or review existing tools and improve where needed.• Develop, validate and document programs for ad-hoc analyses.• Assess the time needed to develop programs and can at least partially self-manage the work.• Take responsibility to deliver a support in time in function of stakeholders needs.

Nairobi, Kenya

• Programming and validating datasets and SDTMs, including complex efficacy, labs, etc.• Programming complex non efficacy outputs/ figures• Developping and debugging complex macros• Creating, QC'ing and updating complex dataset specifications (including efficacy) for single/ multiple studies• Reviewing study design SAP• Reviewing shells and providing feedback• Knowledge, interpretation and implementation of current SDTM, ADAM standards• Knowledge of FDA CRT requirements including define.xml and define.pdf• Leading team and creation of CRT packages• Becoming familiar with and following study documentation• Leading teams for furthering programming development• Ensuring company principles are followed rigorously• Archiving study documentation following instructions in supplied SOPs• Acting as a Lead programmer on studies, ensuring quality and timely delivery• Liaising with Study Statistician and Project Manager regarding resourcing and deliverables• Responsible for study level resources• Point of contact for programming issues for the team, proactively ensuring everything is working cohesively• Persuading stakeholders to follow best practice within a trial• Assisting in development of internal training courses • Performing line management roles

• Programming complex SDTM and ADaM datasets.• Programming complex outputs/figures.• Developing and debugging complex macros.• Creating, QC'ing and updating dataset specifications.• Reviewing study design Statistical Analysis Plan (SAP).• Reviewing listings and summary shells and providing feedback.• Awareness of CDISC SDTM and ADaM implementation guidelines.• Creation of CRT packages as part of the team. Understand FDA requirement.• Working as part of a team with the aim of furthering programming development.• Ensuring the principles in the PHASTAR checklist are followed rigorously.• Archiving own study documentation following instructions in supplied SOPs.• Leading a part of the study for single study.• Performing line management roles.

• Programming and validating SDTMs and derived datasets according to given specifications, including CDISC implementation guidelines for SDTM and ADaM.• Programming and validating summary tables, listings and figures.• Developing macros and using existing more complex macros.• Creating, QC'ing and updating dataset specifications.• Reviewing study design Statistical Analysis Plan (SAP).• Reviewing listings and summary shells.• Awareness of CDISC SDTM and ADaM implementation guidelines.• Creation of CRT packages as part of the team.• Working as part of a team with the aim of furthering programming development.• Ensuring that the company's principles are followed rigorously.

Nairobi, Kenya

• Using SAS to produce high quality outputs (tables, figures and listings) that become part of a clinical trial report.• Logically manipulating datasets using datasets programming skills.• Analysing and reporting data from clinical trials.• Working in teams while performing independent Quality Control of other programmers’/statisticians’ data sets and outputs thus ensuring quality and accuracy.• Creating specifications used for mapping raw datasets' variables to SDTM/ADaM datasets.• Reviewing Statistical Analysis Plan, tables, listing, figures and shells.• Sharing of statistical and programming knowledge among the team.

Nairobi, Kenya

• Designing and development of questionnaires and other data capture tools.• Conducting regular training on data capture tools. • Assisted in full and successful implementation of the Electronic Medical Records (EMR) system running on MySQL/SQL. • Data extraction, cleaning and manipulation for analysis and report generation using SQL, R and SPSS. • Development and maintenance of the MS-SQL and MySQL databases. • Supervision of data team thus ensuring quality data entry. • Leading and overseeing Continuous Quality Improvement (CQI) activities such as 5s, . • Discrepancy checks through regular Data Quality Audits (DQAs). • Generating visualizations and reports using MS Excel. • Presentation of reports. • Monitoring all the service areas to ensure that data is accurate, complete, timely and confidential.

Kilifi, Kenya

• Dataset extraction and manipulation using STATA and R.• Statistical analyses using STATA and R.• Report writing and presentation.• Participated in a clinical study that used secondary data for two studies that had been done earlier.• Sharing knowledge among other scientists.

Master Of Science - Msc, Biometry

Bachelor Of Science - Bsc, Statistics, First Class Honors

Kenya Certificate Of Secondary Education (Kcse), A