About this role
Build Your Career at Krystal BiotechThanks for visiting our Career Page. Explore our current opportunities and apply to positions that match your experience, interests, and qualifications.About Krystal BiotechHeadquartered in Pittsburgh, Pennsylvania, Krystal Biotech has rapidly emerged as a global leader in gene therapy since 2016. The global approvals of the first-ever redosable gene therapy reflect our commitment to transforming groundbreaking science into life-changing treatments for patients with high unmet medical needs.Our approach brings together innovative science and technology, rapid and reliable manufacturing, and a patient-focused commercialization model as we continue to advance a robust pipeline of investigational genetic medicines.At Krystal, breakthrough innovation starts with exceptional people.
We foster a collaborative, inclusive, and fast-paced environment where curiosity is encouraged, diverse perspectives are valued, and every employee can make an impact.Whether you're in the lab, on the manufacturing floor, in the field, or supporting our business operations, you'll be part of a company led by its founders, where every role supports our mission to bring transformative therapies to patients around the world.Benefits That Support YouWe offer competitive compensation and a comprehensive benefits package designed to support our employees both at work and outside of it.Equity CompensationMedical and Prescription Drug CoverageDental and Vision InsuranceShort and Long-Term Disability Insurance401(k) With Company Match401(k) Annual Student Loan Match ProgramPaid HolidaysPaid Time OffFlexible Spending Accounts (Health Care & Dependent Care)Health Savings AccountEmployee Assistance Program & Benefits Concierge AppAD&D and Life InsuranceWellness Rewards ProgramSenior BiostatisticianPittsburgh, PAFull TimeClinical DevelopmentExperiencedShareAbout 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.Position Overview:We are seeking a highly motivated Senior Biostatistician to join our Clinical Development team in Pittsburgh. This role will provide broad statistical support across several clinical-stage programs, partnering with Clinical, Regulatory, and Medical along with other cross-functional teams.
This individual will support study design, analysis, interpretation, and reporting throughout product lifecycles, from clinical development through regulatory submission and post-marketing activities.ResponsibilitiesProvide statistical input into the design and execution of clinical trials and other studies supporting clinical development and marketed products.Contribute to endpoint selection, sample size calculations, analysis populations, randomization strategies, and statistical methodologies.Author and review statistical sections of protocols, Statistical Analysis Plans, and other study documents.Develop or oversee specifications for tables, listings, figures, and other statistical outputs.Perform and/or oversee analyses of efficacy, safety, and other clinical data.Support regulatory submissions, label expansions, post-marketing commitments, and responses to regulatory authority questions.Partner with cross-functional teams to interpret and communicate study results.Review datasets, statistical outputs, and analyses produced by internal teams, CROs, and external vendors.Serve as statistical lead for assigned studies and oversee CRO and vendor statistical deliverables.Contribute to Clinical Study Reports, regulatory documents, publications, abstracts, and presentations.Support pooled and integrated analyses across studies and programs, as applicable.Ensure statistical activities comply with applicable FDA requirements, ICH guidelines, GCP, and company procedures.QualificationsMaster’s degree or PhD in Biostatistics, Statistics, or a related quantitative discipline.5+ years of relevant biostatistics experience within pharmaceutical, biotechnology, CRO, or clinical research environments.Experience supporting clinical trials and developing Statistical Analysis Plans, protocols, and Clinical Study Reports.Strong knowledge of clinical trial methodology, statistical analysis, and regulatory expectations.Experience supporting regulatory submissions and interactions with FDA or other regulatory authorities preferred.Experience supporting approved products, post-marketing studies, label expansion, or lifecycle management activities preferred.Proficiency with SAS and/or R.Experience with CDISC standards, including SDTM and ADaM.Experience working with CROs and external statistical programming partners.Experience in rare disease, gene therapy, biologics, or other specialized therapeutic areas preferred.Excellent communication, analytical, organizational, and project management skills.Ability to thrive in a fast-paced environment and manage shifting priorities.Krystal Biotech, Inc. is anEqual Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers.Krystal Biotech, Inc.does not accept unsolicited headhunter and agency resumes.
Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.#LI-CF1ShareApplyApply for this positionRequiredFirst NameLast NameEmail AddressPhoneAddressResumeWe've received your resume. Clickhereto update it.Attach resumeorPaste resumeAttach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) orPaste resumePaste your resume here orAttach resume fileCover LetterAre you willing to relocate?No answerYesNoWhat's your citizenship / employment eligibility?No answerI am a U.S. Citizen/Permanent ResidentNon-citizen allowed to work for any employerNon-citizen allowed to work for current employerNon-citizen seeking work authorizationI am a Canadian Citizen/Permanent ResidentOtherDesired salaryEarliest start date?Are you currently in a commutable distance to our Pittsburgh facilities?*-- No answer --YesNoPlanning to RelocateThe following questions are entirely optional.To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data.
This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated.Learn more.GenderDecline to answerFemaleMaleRace/EthnicityDecline to answerHispanic or LatinoWhite, not Hispanic or LatinoBlack or African-American, not Hispanic or LatinoAsian, not Hispanic or LatinoNative Hawaiian or Other Pacific Islander, not Hispanic or LatinoAmerican Indian or Alaskan Native, not Hispanic or LatinoTwo or More Races, not Hispanic or LatinoMENA (Middle Eastern and North African)Human Check*Submit Application