The company:
A small pharmaceutical company that specializes in the development of drugs for infectious diseases. Their mission is to make a significant contribution to global health by developing and commercializing safe and effective therapies to combat infectious diseases. They are seeking a highly skilled and experienced Principal Statistical Programmer to join our team on a contract basis, for a minimum of 6 months on a fully remote basis.
The responsibilities:
Lead and manage all statistical programming activities for clinical trials, including developing, testing, validating, and maintaining programs and datasets for statistical analysis.
Ensure that all statistical programs and outputs are of high quality, accurate, and compliant with regulatory guidelines and company standards.
Collaborate with biostatisticians, clinical data managers, and other cross-functional team members to ensure that study designs, data collection, and analysis plans are optimal.
Develop and maintain standard operating procedures (SOPs) for statistical programming and provide guidance and support to other programmers as needed.
Review and provide input on statistical analysis plans, clinical study reports, and other documents related to clinical trials.
Ensure that all study-related data are maintained and documented in accordance with regulatory requirements.
Keep abreast of industry trends and advancements in statistical programming, and incorporate best practices into our processes.
About you:
Bachelor's or Master's degree in computer science, statistics, mathematics, or a related field.
8+ years of experience in statistical programming, with a strong understanding of CDISC standards.
Experience working in a pharmaceutical or biotech company, with a focus on infectious disease.
Excellent knowledge of SAS programming language and related statistical software.
Demonstrated experience in leading programming activities for clinical trials, including the ability to manage timelines and resources.
Strong problem-solving and communication skills, with the ability to work collaboratively with cross-functional teams.
Demonstrated ability to work in a fast-paced environment with a high degree of accuracy and attention to detail.