Statistical Programmer

We are seeking an experienced and highly skilled Senior Statistical Programmer with expertise in SDTM to join our dynamic team. This role is crucial for developing and validating statistical programs that support clinical trials and regulatory submissions. The ideal candidate will have a strong background in SAS programming and a keen eye for detail, contributing significantly to the quality and integrity of our data.

Key Responsibilities

• Develop and validate SAS programs for the creation of SDTM datasets, ensuring adherence to CDISC standards.
• Generate CRF annotations, SDTM specifications, and SDTM development documentation.
• Create and maintain Study Data Reviewer's Guides (SDRG) and Define.xml files.
• Perform rigorous quality control checks on statistical programs and outputs.
• Collaborate effectively with cross-functional teams, including statisticians, data managers, and clinical scientists.
• Ensure compliance with regulatory requirements and internal standard operating procedures.
• Contribute to the continuous improvement of programming processes and methodologies.

Requirements

• Minimum of 5 years of relevant experience in statistical programming within the pharmaceutical or clinical research industry.
• Proficiency in SAS programming, including advanced macro writing and data manipulation techniques.
• Extensive experience with CDISC SDTM standards and implementation.
• Demonstrated experience in CRF annotation, SDTM specifications writing, SDTM development, and validation.
• Familiarity with SDRG and Define.xml creation.
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.
• Ability to work independently and manage multiple tasks effectively.

What We Offer

• Opportunity to work on diverse and impactful clinical research projects.
• A collaborative and supportive work environment.
• Professional growth and development opportunities.
• Flexible working arrangements (remote/hybrid).
• Competitive compensation package.