Principal Biostatisticia

3 days ago Be among the first 25 applicants Direct message the job poster from Talent Match Africa. Work from our offices in Nairobi, Kenya About Us Talent Match Africa connects experienced professionals in Africa with international employers from around the world (USA, Australia, UK, India, Europe). Since 2016, we have provided employability services to professionals across technology, finance, digital marketing, graphic design, and more. We currently have several permanent roles available at our offices in Nairobi, Johannesburg (Sandton), and Durban (Umhlanga), working for incredible international companies. Principal Biostatistician Overview The role of a lead statistician involves overseeing statistical activities for clinical trials or observational studies, serving as a key contact for cross‑functional teams, and ensuring the accuracy and quality of statistical analyses and reporting. Key Responsibilities Statistical Leadership & Study Design Lead statistical activities from study design through reporting for clinical trials and observational studies Serve as primary statistical contact for cross‑functional study teams and client stakeholders Develop protocol components including study design, sample size calculations, randomisation schemes and statistical methodologies Provide statistical oversight to ensure quality and consistency with project requirements Analysis & Reporting Develop comprehensive Statistical Analysis Plans (SAPs) and Table/Figure/Listing (TFL) shells Author statistical methods sections for clinical study reports Review and ensure accuracy of statistical tables, figures, data listings and report text Maintain consistency between summary tables and source documentation Quality & Compliance Demonstrate extensive understanding of statistical concepts and methodologies Recognise and correct flaws in scientific reasoning and statistical interpretation Identify inconsistencies in presentation, inference and adherence to report guidelines Ensure project‑wide consistency and compliance with FDA regulations Guide and review work of junior statisticians and programming teams Effectively mentor peers on statistical methodology and best practices Provide training to less experienced statisticians Manage statistician activities across projects, coordinating assignments and ensuring timely, high‑quality deliverables Required Qualifications Education & Experience MS in Statistics/Biostatistics with 4‑8 years of experience, OR PhD in Statistics/Biostatistics with 2‑4 years of experience Pharmaceutical, CRO, or related industry experience with clinical trials Experience with regulatory agency interactions, especially FDA Technical Skills Expert knowledge of statistical methodologies for clinical trial design and analysis Proficiency in statistical programming software (SAS, R, or equivalent) Deep understanding of FDA regulations and ICH guidelines (E3, E9, E9‑R1) Experience with adaptive designs, interim analyses, and complex study designs Knowledge of CDISC standards (SDTM, ADaM) Expertise in sample size/power calculations and randomization procedures Proficiency in interpreting and applying statistical guidance documents Analytical Thinking : Ability to evaluate complex data, identify methodological flaws, and propose alternative analytical approaches Attention to Detail : Meticulous review capabilities to ensure accuracy and consistency across all deliverables Scientific Rigor : Strong foundation in statistical theory with practical application to drug development Regulatory Knowledge : Understanding of drug development processes and regulatory requirements Therapeutic Area Experience Strong experience in one or more therapeutic areas (oncology, cardiovascular, neurology, immunology, rare diseases, etc.) Work Arrangement ✅ Work on‑site from our office ✅ Be willing to work non‑traditional local office hours ✅ Be excited about a global opportunity with an international company ✅ Have excellent written and verbal communication skills in English Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Information Technology and Research Digital Accessibility Services and Research Services We make hiring decisions based on your experience, skills and passion, and how you can enhance our clients' businesses and culture. When you apply, please tell us the pronouns you use and any reasonable adjustments you may need during the interview. Contact Please note that referrals increase your chances of interviewing at Talent Match Africa by 2x. #J-18808-Ljbffr