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Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.
DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception, DNDi has developed eight new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.
DNDi Africa was established in 2003 in Nairobi to ensure connection with our founding partner KEMRI and support clinical development programmes. This DNDi regional office conducts R&D projects in the Eastern Africa region (esp. Kenya, Uganda, Sudan, Ethiopia, Tanzania), including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, mycetoma, and others. It also leads capacity strengthening initiatives through multi-country research platforms with the objective to ensure sustainable R&D capacities for DNDi projects. The team has grown to approx. 35 people today. As part of the global strategy, DNDi is further empowering its regional teams to ensure a coherent regional development across disease areas and activities, while reinforcing coherence among disease clusters.
Purpose of the position
This position supports the Data Management Team to ensure that all project data is analyzed and subjected to the required statistical tests based on the protocol and study designs and that final consistency checks on the data is done to assure its validity and completeness before any analysis can take place.
Specific job responsibilities
- Contribute to the design of the study protocols including sample size estimation and power analysis.
- Perform random number generation and patient allocation for RCT
- Develop Statistical Analysis Plans (SAP)
- Write analysis programmes to meet specifications of the SAP
- Write and review the relevant statistical Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs)
- Analyze and interpret the data from clinical trials and other studies
- Liaise with the Senior Manager Data Centre and coordinating office (Regional Operations Manager) to develop quarterly and yearly work-plans to determine activities and targets for the period.
- Identify and resolve data discrepancies in liaison with data managers
- Participate in validation of Clinical Data Management Systems including edit check programmes
- Support study team in developing data collection tools and preparing data entry templates
- Contribute to CRF design and all other data management and statistical documentation
- Perform additional management activities as required to provide high quality data for the purposes of analysis and/or regulatory submissions database creation and testing
- Maintain strict confidentiality of all privileged information regarding data and the organization
- Assist in writing the statistical section of the CSR
- S/he reports to the Head of Regional Clinical Operations
- Close working relationship with the Senior Manager Data Center, relevant members of the DNDi African regional office, Nairobi and DNDi global disease teams
Skills and attributes
- Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
- Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
- Strong communication skills in multicultural, multi-lingual environments
- Strong ability to work effectively as part of a multicultural team
- Well organized and structured
- Strong analytical skills
- Strong ability to provide high level support in project/programme delivery
- Strong ability to manage medium/large projects with budget management
- Strategic thinking and leadership abilities
- Strong management, negotiation, and advocacy skills
- Has autonomy for taking actions and decisions
- Strong ability to interact with external stakeholders
- Lead and motivate a small team for optimum performance, supervising junior staff
- Minimum 6 years’ relevant experience in which at least 4 years at Senior Officer level
- Proven ability to work effectively in a team environment and matrix structure
- At least 3 years’ experience in managing large amounts of data, including writing data validation and consistency checks. Previous work on multi-centre clinical trials would be an added advantage.
- BSc Statistics with MSc in Statistics or Epidemiology
- Travel up to 50%
- Please submit your application using the online form
- Deadline for application: Accepting applications until 10 February 2021
- Only shortlisted candidates will be contacted
- Application submission for this position may close early if we have enough suitable applicants