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X4 Pharmaceuticals
Boston, Massachusetts, United States
1 day ago

Description

Reporting to: 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 for patients suffering with rare diseases, including primary immunodeficiencies (such as WHIM syndrome) and rare cancer?  Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the overall health of patients for the first time? If yes, we encourage you to share more about you and your career goals.

X4 is focused on restoring healthy primary immune system function by developing novel therapeutics for the treatment of rare diseases. Our patients have no options to improve their health or quality of life. We know that developing innovative, new medicines is highly challenging and we invite new colleagues who share our values and commitment to support them.  

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.

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.



Job Information

  • Job ID: 58035390
  • Location:
    Boston, Massachusetts, United States
  • Position Title: Associate Director, Statistical Programming
  • Company Name: X4 Pharmaceuticals
  • Job Function: Biostatistics
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 7-10 Years

Please refer to the company's website or job descriptions to learn more about them.

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