The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases affecting millions of the worlds poorest people. Together with more than public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients. 13 new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We aim to deliver a total of 25 new treatments by addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID-19) and climate-sensitive diseases (such as dengue) with a focus on the needs of patients in low- and middle-income countries. With more than employees of 30+ nationalities located in nine offices on four continents, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply. The R&D organisation drives therapeutic innovation from the lab bench to the patient bedside. It develops DNDis portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDis virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICs clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDi functions, beyond R&D. The R&D organisation include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Integrated Clinical Development Sciences (Drug Safety & Pharmacovigilance, Clinical Quality Assurance and Translational Sciences), Regulatory Sciences, Global Clinical Operations, R&D Portfolio and Planning, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organisation for all other topics. Counting the Kenya Medical Research Institute as a founding partner and numerous collaborations with science and access leaders in the broader East African region, DNDi established itself in in Nairobi. An integral part of DNDis global network, DNDi Eastern Africa nurtures R&D and access partnerships across East Africa and beyond, while contributing to DNDi's global strategy. It hosts key global functions such as global clinical operations, communications, policy advocacy and operations. It leads regional networks and initiatives in R&D and access such as the Leishmaniasis East Africa Platform, and is also home to DNDis Data Centre, processing and leading the statistical analysis of clinical trials data for DNDi and a growing cadre of African global health and science groups. Purpose of the position This position supports the Data Management and Biostatistics 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), TLF shell and dataset specifications for SDTM and ADaM.Be an SDTM and ADAM expert providing advice and training.Writing analysis programs to meet specifications of the SAP/lead statistical programming activities as trial programmer as well as making statistical programming decisions/recommendations at study/project level.Maintain proficiency in SAS and awareness of developments.Identify areas where new processes are required as well as create, review and update SOPs and Study Specific Procedures (SSPs).Analyzing and interpreting data from clinical trials and other studies.Liaise with the Senior Manager, Data Management and Biostatistics 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 programs.Support study team in developing data collection tools and preparing data entry templates.Contribute to Case Report From (CRF) design and all other data management and statistical documentation.Perform additional management activities as required to provide timely and 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 and ensure the CSR accurately describes the statistical methods and results of analyses.Ensure appropriate analysis procedures are used in statistical analyses.Create case report tabulations (CRT) from clinical trial data.Ability to work on multiple projects, plan, organize and prioritize activities.Be aware of up-and-coming changes to regulatory guidelines/requirements and awareness of emerging standards and associated impact to ongoing and future planned trials.Build and maintain effective working relationships with cross-functional teams.Comply with organization and industry standards (e.g. CDISC) and processes.Mentor other staff on statistical analysis/statistical programming. Reporting line This position reports to the senior biostatistics manager.Close working relationship with the Senior Management Team. Job requirements Skills and attributes Proficient SAS programming skills.Excellent knowledge of and experience with CDISC standards (e.g., programming of SDTM and ADaM datasets, both production and validation).Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.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 environmentsStrong ability to work effectively as part of a multicultural team.Well organized and structured.Strong analytical skills and ability to critically review data.Strong ability to provide high level support in project/program 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.Thorough knowledge of and experience with CDISC standards is desired. Experience Over 5 years of CRO/Pharma industryProven 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 Education BSc Statistics with MSc in Statistics or related field
