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Principal Statistical Programmer at Intercept Pharmaceuticals. POSITION SUMMARY:. As Intercept continues to build its position as the leader in rare and serious liver disease, we are seeking a Principal Statistical Programmer. The Principal Statistical Programmer is responsible for supporting the statistical programming efforts for a compound program, including developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise for the development of SAS programming standards and procedures.. JOB RESPONSIBILITIES:. • Ensure departmental or functional training plans in place and appropriate. • Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget. • Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications. • Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications. • Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentation of all programming activities. • Manage datasets and output across SAS programs, studies, and indications to ensure consistency. • Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests. • Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures. • Develop and/or maintain departmental procedures and standards. • Review CRFs, edit check specifications, and table, figure, and listing mock-ups. • Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer’s guide documents. • Assist in validation of SAS per 21 CFR Part 11. • Train and mentor new members and programmers; supervise contract programmers, as needed. QUALIFICATIONS:. • Bachelor’s degree in Statistics, Mathematics, Computer Science or a related field required. • Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer. • Prior experience overseeing statistical programming contractors required. • Compound oversight experience highly preferred. • Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. • Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred. • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines. • eCTD NDA submission experience is a must. . REQUIRED KNOWLEDGE AND ABILITIES:. • Ability to travel up to 5% required, which may include overnight and/or weekend travel. • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines. • Exceptional interpersonal skills and problem-solving capabilities . • Proven meeting planning skills . • Ability to work effectively across a matrix organization . • Ability to work independently and collaboratively . • Ability to prioritize with minimal daily instruction . • Ability to think strategically to improve current processes . • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner. • Demonstrate excellent leadership skills within department; this includes taking an active role in departmental and company activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate. • Works effectively with cross functional groups, study team, and vendors . • Adheres to departmental and regulatory agency procedures and standards. • Strong verbal and written communications skills. • Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows. • Consistent demonstration and embodiment of our Corporate Beliefs: Passion for Innovation; Think Big, Act Small; Learn to Dare; and Teams Build the Future. • Ability to have fun and thrive in a growing, diverse, and inclusive work environment. Company Location: United States.