Principal/Associate Director, Statistical Programmer

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 

• 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 

 Qualifications  

• 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