The Indonesia Research Partnership on Infectious Diseases (INA-RESPOND) is a collaborative clinical research partnership between the Directorate General of Advanced Health (Keslan) of the Ministry of Health (MoH) of the Republic of Indonesia  and the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH) of the United States of America, with RSPI Prof. Dr. Sulianti Saroso (RSPI SS) serving as the official host institution and implementer as stipulated in the Decree of the Ministry of Health.

The partnership was formed to jointly build and capitalize on opportunities to rapidly launch a research response to emerging infectious disease threats and to benefit the international community by conducting high quality, collaborative, and sustainable infectious disease research. 

The partnership has completed observational and interventional studies on a variety of diseases, including HIV/AIDS, tuberculosis, COVID-19, acute febrile illness, pneumonia, and schistosomiasis (publication list). 

All research activities are coordinated through INA-RESPOND Secretariat, the operational hub, now based at the National Brain Center Hospital (RS PON). The INA-RESPOND Secretariat maintains the capacity and expertise needed to conduct independent clinical research, including study implementation, protocol development, monitoring and regulatory, laboratory testing, biostatistics, finance, administration, data management, IT, manuscript writing, and project management.

The Biostatistician / Data Management & Biostatistics Section Lead will provide biostatistics and data analysis expertise to INA-RESPOND. This includes collaborating on the development of clinical research studies, from drafting clinical study protocols to choosing appropriate study designs and sampling methods to data collection, management, analysis, and preparation of data summaries and reports for the publication of research findings.

This is a full-time position based in Jakarta that offers one day of remote work per week, offering the opportunity to shape and advance collaborative infectious disease research of national and global importance, with the possibility of serving as a Principal Investigator in line with applicable requirements. 

Reporting Line / Supervisor: This position reports directly to the INA-RESPOND Deputy Head

Supervisory Role: Directly supervise Data Management & Biostatistics Section staff and oversee other Secretariat staff contributing to data management activities within INA-RESPOND.

DUTIES AND RESPONSIBILITIES:

• Leads the development of Statistical Analysis Plans (SAPs) in coordination with the study Principal Investigator
• Conducts statistical analyses of study data according to the SAPs, accurately and completely to identify relationships and trends in data, as well as any factors that could affect the results of research.

• Adapts statistical methods and approaches to solve specific problems.
• Develops statistical programs and scripts to review data for consistency, accuracy, and quality.
• Supports the development of periodic reports.
• Assists in the preparation of study results for manuscripts in scientific journals and presentations at scientific conferences.
• Assists in the preparation of final study reports.
• Presents analysis results in meetings or conferences to various audiences, including partnership stakeholders, study sponsors, and peers.
• Develops and applies biostatistical theory and methods to the analysis of clinical and medical data related to safety and efficacy.
• Oversees the reviews and annotations of Case Report Forms (CRFs); assists in producing/validating e-submission (eCRT, eCTD, define.xml) packages.
• Produces summary tables, data listings, and graphs (TLGs) using statistical software.
• Provides technical leadership and mentorship to subordinates, early-career staff, investigators, collaborators, and other researchers working with INA-RESPOND.
• Works with data management staff to implement database QA/QC and related processes to ensure database accuracy and integrity.
• Other duties as assigned.

QUALIFICATIONS, SKILLS, AND EXPERIENCE:

Required:

• Master’s degree in biostatistics/statistics, public health, epidemiology, or data science; 
• Experience working as a biostatistician for health research studies for a minimum of 3 years with strong technical skills.
• Interpersonal and team skills, with capability to lead complex teams consisting of Indonesian and international clinicians, scientists, operations specialists, and others.
• Fluency in English and Bahasa Indonesian, having high proficiency with written and verbal communication.
• Knowledge of clinical research databases, data security, documentation, and records management
• Detail-oriented and highly organized, being able to manage multiple databases and analyses at a given time.
• Strong critical thinking, analytical, problem solving, and troubleshooting skills. 
• Knowledge of clinical research data management workflows and datasets
• Experience working with different statistical platforms, such as R, Python, SAS, SPSS, or Stata
• Advanced level of supervisory and management skills, with interest in teaching and mentoring.

Preferred:

• Doctoral degree (PhD) in biostatistics/statistics.
• Experience with clinical research databases (e.g. DFdiscover, REDCap, and Open Clinica)
• Experience with SDTM and ADaM standards
• Experience publishing scientific manuscripts in international peer-reviewed journals 
• Advanced programming skills (e.g., in R or Python) for automation and visualization.