3 дня назад
Senior Biostatistician
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Biostatistician (Clinical Trials/SAS): Developing statistical analysis plans, randomization schedules, sample size calculations, and regulatory submission materials for phase 1–4 clinical studies with an accent on SAS programming, CDISC standards, and drug development knowledge. Focus on leading studies and submissions, supporting unblinded DSMB analyses, reviewing protocols and clinical reports, and solving complex statistical and regulatory challenges.
Location: Home based in South Africa; locations include Bloemfontein, Johannesburg, Pretoria, Cape Town, Durban, Free State, Gauteng, Western Cape, KZN, North West, or Eastern Cape
Company
is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data analysis and regulatory submissions.
What you will do
- Create randomization and kit schedules in collaboration with sponsors and randomization and drug supply management teams.
- Develop phase 1–4 statistical analysis plans, integrated SAPs, and TLF shells.
- Review ADaM datasets and TLFs, resolve comments with clients and programmers, and prepare statistical methods and results for clinical study reports.
- Perform sample size calculations and provide statistical input on sponsor protocols, study designs, objectives, and regulatory submissions.
- Lead projects, study programs, and submissions while managing client meetings, timelines, scope, and resource estimates.
- Support Data Safety Monitoring Boards as an unblinded statistician and collaborate with regulatory, project management, sponsor, and medical writing teams.
Requirements
- Degree in Biostatistics, Statistics, Mathematics, or a related discipline; a master's degree or PhD is preferred.
- At least 5 years of experience in biostatistics or a similar field.
- Strong SAS programming skills, including SAS Base and SAS Macro, with experience producing TLGs.
- Thorough knowledge of clinical data, drug development, clinical trials, and pharmaceutical development.
- Strong knowledge of CDISC, especially SDTM and ADaM, and familiarity with FDA, ICH, GCP, and 21 CFR Part 11 requirements.
- Excellent scientific writing, communication, organization, problem-solving, and collaboration skills.
Culture & Benefits
- Home-based work arrangement in South Africa.
- Collaborative and inclusive work environment.
- Opportunity to contribute to clinical research across pharmaceutical, biotech, and medical device industries.
- is Great Place to Work certified and recognized for employee retention and customer satisfaction.
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