MS in Statistics, Computer Science, or related field with 8+ years of SAS programming experience, or BS with 10+ years.
Proven experience leading statistical programming for regulatory submissions.
Demonstrated ability to manage CRO relationships and oversee deliverables.
Experience supporting early and late phase clinical trials and regulatory submissions (NDA, MAA).
Strong hands-on SAS programming skills and in-depth knowledge of CDISC standards.
Familiarity with FDA electronic data submission requirements and clinical data management concepts.
Excellent communication, organizational, and problem-solving skills.
Responsibilities
Design and develop SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH, and SAS MACROS.
Develop CDISC-compliant SDTM and ADaM datasets.
Execute statistical analysis and reporting deliverables (TFLs) timely and accurately.
Provide input on case report forms and clinical study databases.
Collaborate with teams for quality support in clinical trial analysis and reporting.
Oversee statistical programming activities and manage projects with CROs.
Perform quality control checks on SAS code and outputs from vendors.
Benefits
Opportunity to work on impactful clinical trials and regulatory submissions.
Collaborative environment with cross-functional teams.
Professional development and training opportunities.
Flexible work arrangements to manage work-life balance.
Full Job Description
Accountabilities and Responsibilities:
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
About X4 Pharmaceuticals, Inc.
X4 Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases. The company's lead product candidate, mavorixafor, is a potential first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. X4 Pharmaceuticals is also developing X4P-001, a potential first-in-class, oral, small molecule antagonist of CXCR2, currently in Phase 1 development for the treatment of severe congenital neutropenia (SCN), as well as several other preclinical programs.
