What are the responsibilities and job description for the Principal/Associate Director, Statistical Programmer position at Priovant Therapeutics?
Overview
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Principal/Associate Director Statistical Programmer will help advance this mission by providing programming support across therapeutic areas and in all phases of clinical development. S/he will report to the Director of Statistical Programming in the Biometrics department.
Responsibilities
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Principal/Associate Director Statistical Programmer will help advance this mission by providing programming support across therapeutic areas and in all phases of clinical development. S/he will report to the Director of Statistical Programming in the Biometrics department.
Responsibilities
- Provide programming support for the clinical trials as assigned that includes but not limited to:
- Review of case report forms and EDC for data integrity
- Development of SDTM and ADaM datasets, specifications and CDISC components from completed and ongoing studies
- Development and execution of blinded dry run and reporting tables, listings and figures
- Review of analysis plans from a programmer's perspective
- Review of IDMC output and algorithms, where needed
- Ad-hoc support for study teams that includes production and validation for internal needs
- Programming support for DSURs, Integrated Safety Summaries, patient profiles, etc.
- Ensure accurate and compete TMF, for inspection readiness
- Rapid turn-around for regulatory request for information (RFIs)
- Provide oversight (as needed) of Statistical Programming from CROs by ensuring the programming tasks are completed and delivered in accordance with timelines and data quality standards
- Master's degree in computer science, biostatistics or related field with 5 years of experience or bachelor's degree with 7 years relevant experience
- Expert knowledge in SAS (SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACRO, SAS/ODS)
- Advance knowledge and experience with SDTM Implementation and ADaM implementation according to CDISC Standards
- Knowledge of statistics procedures within SAS/STAT and experience leading a phase 2 or phase 3 study reporting effort from database build to study read-out and archival.
- Organized and thorough with very high attention to details
- Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
- Demonstrated excellent communication (written and verbal), problem-solving, and decision-making skills
- Natural collaborator who enjoys working on a cross-functional team