Statistical Programmer

Statistical Programmer

About Krystal Bio:
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. 

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end to end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. 

Krystal is headquartered in Pittsburgh, PA which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. 

Job Description Summary:
Krystal Biotech, Inc. is seeking a Statistical Programmer who will play a critical role in supporting clinical trials by developing and validating statistical programs for data analysis and reporting. This position involves collaborating closely with biostatisticians, data managers, and clinical teams to ensure the accurate and efficient analysis of clinical data. The ideal candidate will have a strong background in statistical programming, with expertise in SAS and other statistical software.

Responsibilities will include, but are not limited to, the following:

• Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis.
• Develop and maintain SDTM domains in accordance with CDISC guidance.
• Create and optimize ADaM datasets, Tables, Figures, Listings (TFLs) and Analysis content
• Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications.
• Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities.
• Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis.
• Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.
• Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
• Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies
• Work closely with data management teams to ensure the integrity and accuracy of clinical trial data.
• Review deliverables before transfer to either internal or external clients.
• Collaborate with biostatisticians to develop statistical analysis plans (SAPs) and ensure alignment between programming outputs and study objectives.
• Participate in cross-functional team meetings, contributing to discussions on study design, data analysis, and interpretation of results.
• Stay current with industry trends, new programming techniques, and software tools to enhance the efficiency and effectiveness of statistical programming activities.

Requirements and Preferred Qualifications:

• Minimum of a Bachelor’s Degree required; MS degree is preferred (statistics, biostatistics, or closely related field).
• 10+ years’ experience with SAS and clinical programming within the biotech / pharmaceutical industry.
• Proficiency in SAS programming, including experience with SAS macro language, data step programming, and PROC SQL.
• Strong knowledge of CDISC and CDASH standards, including SDTM and ADaM datasets, and experience with regulatory submission requirements.
• Experience with clinical trial data and understanding of the drug development process.
• Knowledge of regulatory guidelines, including FDA, EMA, and ICH, related to statistical programming and clinical trials.
• Experience with statistical programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required.
• Drug filing (BLA/MAA) experience highly preferred.
• Proficiency in industry standards, medical terminology, and clinical trial methodologies.
• Vendor/CRO management experience.
• Excellent problem-solving skills and attention to detail, with the ability to work independently and manage multiple projects simultaneously.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.