Lead Statistical Programmer - Sponsor Dedicated

In this role, you will take a leading position in the programming and delivery of complex clinical study datasets and statistical outputs for global pharmaceutical trials. You will oversee SDTM, ADaM, and TLF development, ensuring high-quality results while mentoring junior team members. Working closely with cross-functional teams such as Clinical, Medical Writing, Safety, and Biometrics, you will coordinate programming activities, manage resources, and contribute to submission activities. This position offers flexibility to work remotely across EMEA or from a local office and provides opportunities to influence study processes and standards. Attention to detail, strong technical expertise, and the ability to work collaboratively in a fast-paced environment are key for success in this impactful role.

• Plan, execute, and oversee all programming activities for clinical studies, including resource estimation, budgeting, timeline management, and quality assurance.
• Supervise the development of SDTM, ADaM, and TLF datasets and perform senior reviews of outputs.
• Collaborate with cross-functional teams to support additional programming needs for publications, medical writing, and other analyses.
• Lead and support submission activities, ensuring compliance with regulatory standards and data submission requirements.
• Set up programming tools and macros to maximize efficiency while maintaining the highest quality standards.
• Mentor junior programmers on best practices for SDTM, ADaM, and TLF development and adherence to department standards.

• Degree in mathematics, life sciences, statistics, computer sciences, or equivalent professional experience in statistical programming within clinical trials.
• Minimum 5 years of experience with complex clinical trials and associated datasets, including safety and efficacy endpoints.
• Prior experience in a lead programming role is preferred.
• Comprehensive knowledge of clinical trial processes, including study setup, data management, and biostatistics.
• Expert knowledge of Base SAS, SAS macros, SAS/STAT, and debugging techniques.
• Broad understanding of CDISC standards, including SDTM, ADaM, define.xml, Reviewer's Guides, and submission requirements.
• Strong analytical, collaborative, and detail-oriented work style.
• Excellent communication skills in English, both verbal and written.

• Competitive salary and comprehensive benefits package.
• Flexible remote working options across EMEA or from local offices.
• Opportunities for professional development and mentoring.
• Exposure to global clinical trials and cross-functional collaboration.
• Chance to contribute to impactful projects in the pharmaceutical industry.
• Supportive work environment fostering autonomy and career growth.