Head of Statistical Programming

Principal Duties and Responsibilities:

• Provides functional expertise and leadership to support the clinical study teams, including deployment of programming strategies, standards, specifications, and programmed analyses to comply with regulatory requirements, SOPs and work practices
• Take initiatives to develop and implement innovative strategies and technologies for statistical programming
• Proactively plan, implement, and identify issues/risks and provide remediation strategies
• Manage multiple direct reports (all aspects of hiring, mid-year and annual reviews, promotions/demotions and termination)
• Set, manage, and meet realistic timelines for programming activities and oversee the programming budget
• Lead electronic data submission preparation and review
• Review statistical analysis plan and other study documents, provide input, and assess impact on programming activities
• Participate in the development of Clinical Study Reports, Investigator Brochures, NDAs/BLAs, Annual Reports/DSURs, INDs
• Develop SOPs, job aides, and training
• Ensure that statistical programming tasks are conducted in compliance with GCP, TRACON SOPs, applicable regulatory requirements, CDISC data standards, and industry best practices
• Select and manage vendors as necessary
• Manage data analysis and output in accordance with protocol requirements (e.g. interim, final and data monitoring committee meetings), for publication, TRACON board meetings (e.g. safety, scientific, corporate), and clinicaltrials.gov postings
• Oversee the training of staff in the use of software applications that support biometrics activities
• Oversee the use of data standards for data collection and creation of SDTM and ADaM datasets
• Oversee programmers using R, SQL, SAS, Python, or other languages as necessary and ensure the control of data, code, and outputs in compliance with 21 CFR Part 11 and other applicable guidance and regulations
• Participate in the validation of software applications that support clinical data management, biostatistics and programming
• Participate in the qualification of environments for programming and reporting
• Communicate with commercial software solution vendor(s) regarding identified bugs and requested software improvements

Qualifications:

• Education

• Master’s degree or higher in computer science, statistics, biostatistics, or related field  

Experience/Skills

• Minimum of fifteen years of statistical programming experience in the biotechnology or pharmaceutical industry
• Minimum of five years of management experience
• BLA/NDA filing experience (recent BLA/NDA filing experience within the past 5 years preferred)
• Mastery of SAS for data analysis, visualization, and reporting
• Demonstrate understanding of all applicable regulations and guidelines governing drug development including ability to apply these to overall strategic drug development
• Broad expertise in statistical programming and in developing computing strategies
• In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases
• Excellent working knowledge of Good Clinical Practices; ICH guidelines; trial initiation and management practices and procedures
• Excellent leadership, interpersonal and communication skills
• Works efficiently with others to accomplish goals and resolve problems; encourages cooperation, collaboration, and co-ownership of processes

Position Requirements:

• Ability to work on complex problems where analysis of situations or data visualization requires an in-depth evaluation of various factors
• Willing to travel for training, audits, conferences, or other events or meetings in support of biometrics or corporate goals