Director, Statistical Programming in Boston, Massachusetts at X4 Pharmaceuticals INC

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear, profound impact on patients with rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals.

X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency. We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

Reporting to the Senior Director, Biostatistics, you will be responsible for overseeing statistical programming activities across X4’s portfolio, managing CROs, providing hands-on programming support and technical guidance on clinical trials and regulatory submissions, building and maintaining programming infrastructure, and ensuring compliance with SOPs to produce quality and timely deliverables. He/she must possess extensive experience and proven skills in the use of SAS and complete knowledge and understanding of the statistical programming processes, procedures, and roles. He/she will use knowledge of CDISC SDTM and ADaM standards to statistical analysis, including generating analysis data, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, this individual will participate in departmental and cross functional technology development and process improvement initiatives.

• Effectively design and develop SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
• Develop and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.
• Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality manner.
• Provide input in the design and development of case report forms and clinical study databases.
• Collaborate with cross-functional teams to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, and product launch.
• Drive and oversee Statistical Programming activities internally and externally (CRO), and act as project manager for statistical programming deliverables.
• Assess and perform quality control checks/validation of SAS code and output produced by vendors or other Statistical Programmers for SDTM datasets, ADaM datasets, and TFLs.
• Author and review SDTM and ADaM datasets specifications for datasets programming.
• Create and review eCTD documents to support regulatory submission package.
• Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
• Participate in the development and review of relevant SOPs.

What You Will Bring:

• MS in Statistics, Computer Science or a related field with at least 8 years (or BS in Statistics, Computer Science or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry.
• Proven experience of independently leading statistical programming activities for regulatory submissions.
• Demonstrated ability to manage CRO relationships and oversee programmed deliverables.
• Experience in providing statistical programming support to early and late phase clinical trials, and regulatory submissions (NDA, MAA).
• Strong hands-on SAS programming skills.
• In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
• Experience in developing programming specifications, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format.
• Familiar with statistical analysis methods and clinical data management concepts.
• Deep Knowledge and experience with FDA and GCP/ICH regulations and guidelines.
• Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
• Excellent written and verbal communication skills along with organizational and documentation skills.
• Excellent attention to detail and problem-solving skills
• Proven project management skills, professional attitude, self-improvement mentality with positive attitude