Minerva, a leading clinical research organization based in Karachi, Pakistan, is seeking an experienced Biostatistician to join our team on a full-time, on-site basis. The successful candidate will play a vital role in supporting clinical research projects through rigorous statistical analysis, data interpretation, and comprehensive research reporting. This position requires a strong foundation in statistics and clinical research, with the ability to manage clinical data effectively and collaborate across multiple departments.
Key Responsibilities
- Analyze clinical research and study data using appropriate statistical methodologies.
- Provide statistical input during the planning and design phases of clinical studies.
- Perform sample size and power calculations as needed to ensure study validity.
- Prepare and contribute to the development of Statistical Analysis Plans (SAPs).
- Conduct detailed statistical analyses and interpret study outcomes accurately.
- Generate statistical tables, graphs, and reports to support study findings.
- Review datasets to detect errors, trends, inconsistencies, and unusual results.
- Collaborate closely with Clinical Operations, Data Management, Regulatory, Quality Assurance, and other relevant teams.
- Communicate statistical results clearly to both clinical and non-statistical stakeholders.
- Assist in the preparation of Clinical Study Reports (CSRs) and scientific publications.
- Ensure all statistical activities comply with approved protocols, Standard Operating Procedures (SOPs), and applicable clinical research standards.
- Maintain meticulous records and documentation of all statistical analyses.
- Support data reviews, quality assurance checks, audits, and regulatory submissions as required.
Required Qualifications
- Bachelor’s or Master’s degree in Biostatistics, Statistics, Mathematics, Epidemiology, or a closely related field.
- Minimum of 3 years of relevant professional experience in biostatistics, clinical research, healthcare, pharmaceutical, or Contract Research Organization (CRO) settings.
- Strong understanding of statistical methods and data analysis techniques.
- Solid knowledge of clinical trials and clinical research processes.
- Proficiency with statistical software such as R, SAS, SPSS, Python, or Stata.
- Advanced skills in Excel and data management.
- Excellent analytical and problem-solving capabilities.
- High attention to detail and accuracy in work.
- Effective written and verbal communication skills.
Preferred Qualifications and Benefits
- Prior experience working within a CRO, pharmaceutical company, or clinical research organization.
- Familiarity with preparing or reviewing Statistical Analysis Plans (SAPs).
- Experience handling clinical trial datasets.
- Knowledge of ICH-GCP guidelines and clinical research standards.
- Understanding of CDISC standards such as SDTM and ADaM is advantageous.
- Preference for candidates with hands-on experience in SAS or R.
What We Offer
- The opportunity to work in a dynamic and growing clinical research organization.
- Exposure to a variety of multidisciplinary clinical research projects.
- Collaboration with experienced teams across Clinical Operations, Data Management, Regulatory, Quality Assurance, and Compliance.
- Professional development and career growth within the clinical research industry.
Minerva is committed to fostering a collaborative environment where your expertise in biostatistics will directly contribute to advancing clinical research and improving healthcare outcomes. If you are passionate about applying your statistical skills in a clinical setting and thrive in a team-oriented atmosphere, we encourage you to consider this exciting opportunity.