We are seeking a highly skilled Senior Statistical Programmer to join our team. The ideal candidate will have extensive experience in statistical programming, particularly using SAS, and will be well-versed in the analysis and reporting of clinical trial data. This role is crucial for the development of Integrated Summaries of Efficacy (ISE) and Integrated Summaries of Safety (ISS) for various therapeutic areas, including Immunology, Respiratory, Asthma, and COPD.
Key Responsibilities:
Develop and validate statistical programs for the analysis of clinical trial data, ensuring compliance with regulatory standards.
Collaborate with biostatisticians and clinical teams to design and implement statistical analysis plans.
Prepare and review statistical outputs, including tables, listings, and figures for clinical study reports.
Contribute to the preparation of Integrated Summaries of Efficacy and Safety, ensuring accuracy and clarity in data presentation.
Maintain documentation of programming processes and ensure adherence to standard operating procedures.
Participate in project meetings and provide updates on programming progress and challenges.
Required Skills:
Proficiency in SAS programming and statistical analysis.
Robust understanding of clinical trial processes and regulatory requirements.
Experience with ADaM and SDTM standards.
Knowledge of therapeutic areas such as Immunology, Respiratory, Asthma, and COPD is preferred.
Excellent problem-solving skills and attention to detail.
Robust communication skills, both written and verbal, to effectively collaborate with cross-functional teams.
If you are a dedicated skilled with a passion for statistical programming and a commitment to excellence, we encourage you to apply for this exciting opportunity.