Head of Biostatistics at Drugs for Neglected Diseases initiative (DNDi)

Purpose of the position

• To lead the DNDi Biostatistics team
• To provide support to disease teams in the design and analysis of new studies
• To ensure that all project data is analyzed and subjected to required statistical tests including the development of tabulation of results, testing of relationships, and development of frequency tables

Specific job responsibilities

• To support in protocol development
  • Contributing to the design of the clinical trials
  • Performing sample size estimation and power analysis
  • Develop and implement randomization procedures.
• To develop statistical documents and analysis
  • Generating Statistical Analysis Plans (SAP)
  • Writing STATA programs to generate Tables, Listings, and Graphs
  • Generate Tables, Listings and Graphs per the specifications provided in the Statistical Analysis Plan
  • Generate Statistical Analysis Reports
  • Support generation of Clinical Study Reports (CSR) and manuscript writing
  • Support DMB staff on performing data management and statistical analysis.
• To support, manage and oversee DMB staff.
  • Develop Action Plan and Quality Objectives for the DMB team
  • To ensure data is managed as per Standard Operation Procedures (SOP) and compliant to regulatory requirements.
  • Liaise with the coordinating office (Regional Finance and Administration Manager) to develop quarterly and yearly work-plans to determine activities and targets for the period.
  • Perform additional management activities as required to provide high quality data for the purposes of analysis and/or regulatory submissions, database creation and testing.
  • Ensure DMB personnel have the necessary training and skills to perform their specific roles.
  • Ensure DMB staff are trained on Good Clinical Practice (GCP) and DNDi SOPs related to data management and statistical analysis.
  • Attend Senior Management Team, Nairobi Cross Disease Task Force, Medical Affairs, Clinical Trial and other management meetings as maybe necessary and required.
• To participate in efforts geared towards improving the effectiveness and efficiency of operations in accordance with the policies and procedures as laid down in the organization’s Quality Manual. 

Reporting line

• The Head of Biostatistics reports to the Head of Global Clinical Operations
• Directly supervises statisticians

Interactions

• Works with disease teams and with other transversal R&D units.
• This role has frequent interaction with DNDi staff and external stakeholders to coordinate provision of work or to advocate, persuade and gain support or commitment. This role represents DNDi for a programme/service area and develop and maintain relationship with current and future partners

Job Requirements

Skills and Attributes

• High ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Very clear and systematic thinking that demonstrates strong judgment and problem solving competencies
• Excellent communication, and public speaking skills, ability to convince and represent DNDi at high level events
• Knowledge of managing global multicultural teams
• Highly organized and structured
• High analytical skills
• High ability to lead large strategic projects
• High ability to manage large size projects with budget management
• Very strong strategic thinking and leadership abilities
• Excellent management, negotiation, and advocacy skills
• High ability to exercise high degree of independence to ensure program delivery and explore new areas of activities
• High ability to interact with internal and external stakeholders
• High ability to lead and motivate a team for optimum performance

Experience

• Over 10 years in Senior role with proven interaction with the US FDA or EMA
• Proven ability to work effectively in a team environment and matrix structure
• Experience of working in public and private sector is highly desirable
• A previous senior position as a biostatistician in multinational, multicenter clinical trials would be an added advantage

Education

• PhD in Statistics or related field with at least 10 years of relevant experience, or Master’s in Statistics or related field with 15 years of relevant experience
• Proven skills in data analysis.

Other Requirements

• Fluency in English
• Proficiency in R or SAS
• Excellent written and oral communication skills
• Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational & business issues.
• Ability to work autonomously and within a team environment
• Excellent knowledge of Microsoft Suite