Contractor – Principal Statistical Programmer Syndax Pharmaceuticals is looking for a Contractor – Principal Statistical Programmer At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Principal Statistical Programmer will provide expert-level hands-on programming support and technical expertise to develop, maintain, validate, and execute SAS programs that access, visualize, analyze, and report clinical trial data in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. The Principal Statistical Programmer performs the statistical programming required for analysis of clinical trial data on projects for in-house and out-sourced clinical trials, commercial requests, Health Economics Outcome Research (HEOR) analyses, pooled analysis such as integrated summary of efficacy (ISE) and integrated summary of safety (ISS) and any ad-hoc analyses as required. The candidate will have a proven ability to work independently, possess excellent communication skills, and have advanced expertise in SAS programming.
Key Responsibilities:- Supports study leads and take ownership of multiple deliverables within a drug program whilst providing support across various drug platforms.
- Acts as an integral member of project team, complementing the lead programmer as required. May attend project team meetings as required and will cross-collaborate with vendors, biostatisticians, data managers, and other cross-functional teams as required.
- Serve in a primary role for production of all tables, listings, and figures, and Case Report Form (CRF) tabulations for clinical trial programs including ISS/ISE.Serve as a primary programmer to support regulatory requests, commercial requests, ad hoc analyses, biomarker analyses, HEOR analyses etc.
- May review critical Standards Artifacts and Processes (such as Statistical Analysis Plans, Data Validation Plans, eCRFs, etc.) and provide constructive comments.
- Troubleshoots and provides quality review of complex SAS programs.
- Follows good programming practices and adequately documents programs.
- Understands and follows FDA regulations which affect the reporting of clinical trial data.
- May participate in cross functional task forces and initiatives representing Statistical Programming.
- Desired Experience/Education and Personal Attributes:
- At least eight years of relevant experience. Exceptional candidates with 5+ years of experience may be considered.
- Bachelor's degree.
- Experience in Oncology required; Leukemia experience preferred.
- Ability to communicate technical concepts clearly and concisely to non-technical colleagues.
- Successfully completed several large or complex projects.
- Ability to handle multiple projects with aggressive timelines.
- Ability to multitask and prioritize work.
- Excellent knowledge of SAS.Familiarity with coding dictionaries (WHO, MedDRA).Expert at industry standard initiatives such as CDISC.Knowledge of medical and statistical terminology.
- Capable of using Windows, Word, and Excel.
Location:
While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations. Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company's pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
