Associate Director, Statistical Programming

Associate Director, Statistical Programming

Reporting to: Senior Director, Statistical Programming

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from 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.

This opportunity will …

• Align with your values and grit, and passion for innovative science.

• Leverage your deep knowledge of statistical programming to support our innovative science and allow you to have a major impact on our mission to support our patients.

• Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.

Accountabilities and Responsibilities:

• Effectively design, develop, and drive SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.

• Create, implement, 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 and mock shells etc.

Requirements: Proven Experience, Skills and Education:

• 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.

• Deep expertise 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.

• Proven ability 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.

• Capability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.

This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.

We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!

About Us

Pipeline

X4 Pharmaceuticals is an Equal Opportunity, and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.

Please note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new employees must have received their complete doses of the COVID-19 vaccine and one booster unless they have been granted an exemption by X4.

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