Deciphera Pharmaceuticals Inc.
Job Title: Director, Head of Statistical Programming
Job Number: 21881
Location: Waltham, MA
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas.
We offer an outstanding culture and opportunity for personal and professional growth based on these key principles:
• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve
This position will report to the Senior Director, Head of Biometrics and be located in the Waltham, MA office.
- Serves as the Head of SAS Programming for all compounds or key NDA related activities
- Effectively manage all members of the SAS programming team, providing guidance, direction, motivation, and professional development
• Efficiently manage CROs to meet timelines and expectation of quality
• Works collaboratively with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines
• Programs for SDTM data mapping and creation of ADaM datasets and the corresponding specifications according to CDISC standards
• Programs TLFs for implementation of the statistical analysis plans and for AdHoc analysis in clinical trial of all phases
• Performs programming QC on TLFs
• Tracks clinical trial milestones and works with vendors for statistical reporting deliverables.
• Maintains records for all assigned projects and archiving of trial/project analysis and associated documentation
• Understands and performs in accordance with regulatory standards, and drug development principles
• Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package
• Plans, develops, tests, and documents SAS macros for programming efficiency
• 8+ years in statistical programming within the Pharmaceutical industry
• Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions
• Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development
• Ability to define and implement CDISC compliant SDTM and ADaM data and specifications
• Oncology experience is a plus