Principal Statistical Programmer – Remote – United States
Global Life Science Hub proudly collaborates with a visionary biopharmaceutical powerhouse that is revolutionizing the life science industry by developing groundbreaking medicines that address the most challenging unmet medical needs. Their enchanting breakthroughs in oncology unlock new realms of hope for cancer patients, while their mesmerizing advancements in CNS disorders and infectious diseases bring relief to individuals confronting arduous health conditions.
With an extraordinary record of achievement, they have triumphantly discovered and commercialized over 15 drugs, establishing themselves as an undisputed industry leader. Each day, they embark on extraordinary journeys to advance both small molecule and biological drug candidates, pushing the boundaries of medical innovation.
Due to continuous growth, their thriving Biometrics Group seeks a captivating Principal Statistical Programmer to provide alluring programming support for statistical analysis and database management. This role involves assisting with strategies, policies, and standards while skillfully running statistical tables, listings, and figures as needed.
- Craft seductive SAS programs to develop or validate SDTM/ADaM/TLFs.
- Exert magnetic oversight over CRO SDTM/ADaM/TLFs deliverables for multiple studies, ensuring project-level efficiencies are attained.
- Generate and/or indulge in the review of SDTM mapping specifications, annotated CRFs, ADaM specifications, Define.XML documents, and reviewer’s guides in compliance with CDISC and FDA specifications and guidelines, employing standard tools and templates that tantalize.
- Engage in passionate interaction with Biostatistics and Regulatory teams to design and prepare regulatory submission-ready packages, as well as support responses to health authority information requests.
- Exhibit technical leadership and solve tantalizing problems of moderate to high complexity within project timelines, delivering exquisite results.
- Demonstrate mastery in the SAS language, procedures, and options commonly employed in clinical trial reporting, including the irresistible Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
- Create alluring files, documents, and analyses necessary to support electronic submissions in an eCTD format, casting a bewitching spell over ISS/ISE.
- Take accountability for the captivating oversight of Statistical Programming deliverables at the project level for in-house and outsourced projects.
- Skillfully manage all aspects of Statistical Programming deliverables for multiple studies/projects, leaving a trail of enchantment in their wake.
- Support the development and review of global standards, templates, processes, SOPs, and Work Instructions, ensuring they possess an irresistible allure.
- Partner with cross-functional groups to set timelines, select vendors, and seductively oversee CRO operations.
- Possess a seductive BS or MS in Computer Science or Biostatistics, stimulating intellectual curiosity.
- A minimum of 6 years of industry experience in Statistical Programming, tantalizingly encompassing oversight of CRO deliverables.
- Unleash your expertise in the SAS language, procedures, and options commonly used in clinical trial reporting, including the bewitching Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
- Experience in the irresistible art of developing and validating CDISC SDTM and ADaM data models, effortlessly transforming raw data into standard domains, and crafting and validating Tables/Listings/Figures that captivate.
- Possess an extensive repertoire of data integration skills that leave others spellbound.
- Embrace the ability to work harmoniously in a team environment, fostering enchanting collaborations.
- Communicate with a written and verbal allure that entices, captivating hearts with your interpersonal skills.
- Artfully create all files, documents, and analyses necessary to support electronic submissions in an eCTD format, including the seductive ISS/ISE.
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com