Biostatistician

☑ Основы вакансии:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: РФ, Москва.

☑ Актуальность объявления:

Это объявление № 28881473 добавлено в базу данных: Вторник, 23 апреля 2024 года.

Дата его обновления на этом интернет-ресурсе: Вторник, 30 апреля 2024 года.

☑ Репутация компании "АстраЗенека":

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☑ Подробности о вакантном месте:

Major Duties and Responsibilities (including supervising others):

• Provides critical clinical programming support to projects.
• Interacts directly and independently with Data Management, Programmers, Clinical Development staff and management as a fully functioning member of the clinical programming team.
• Proactively keeps the manager updated on the status, programming accomplishments and criticality of any issues impacting the quality and timely delivery of statistical Programming outputs.
• Collaborates with external partners, ensuring partners have thorough understanding of expectations.
• Provide oversight for programming deliverables performed by service provider.
• Works independently, with minimal supervision from the manager.
• Actively solcits feedback from manager to address any issues and/or complex problems
• Provides accurate estimates on timelines.
• Leads in the development of analysis data set specifications.
• Independently implements and champions the use of standards and TA specific data listings, summary tables, and figures as specified in statistical analysis plan in the clinical study report.
• Develops robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation.
• Ensures compliance of standards for all statistical programming assignments.
• Reviews and provides feedback on eCRF designs, eCRF annotations, DB structures, edit checks, SAPs and SPPs.
• Proactively offers and provides statistical programming and analytical skills that support clinical trial and/or TA projects and programs.

Requirements/Qualifications:

• Education: Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. Advanced degree preferred.
• Experience: A minimum of 5 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries.
• Special Skills/Abilities:

1. Has acquired advanced SAS programming skills with proficiency in Base SAS, SAS/STAT and SAS/Graph. Able to develop standard SAS macros.
2. Good working knowledge of CDISC guidelines. Good working knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes.
3. General knowledge of medical terminology and clinical trials methodology.
4. Excellent verbal, written, interpersonal and communication skills.
5. Sound negotiation skills. Ability to mentor junior Statistical Programmers
6. Fully understands data interoperability across and amongst the Clinical Data Management
7. Application and all externally collected data.

☑ О компании:

Логотип (эмблема, торговая марка, бренд) компании:

Сфера деятельности компании: Медицина, фармацевтика, аптеки; .

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