Associate Director, Biostatistics And Programming (Remote) - 24-111

Description
The Associate Director, Biostatistics and Programming is a primary resource for the developing/validating of programs/specifications which are used to create datasets (SDTM/ADaM/Derived datasets for ad-hoc analyses) and TFLs in-house or from outside vendors. The Associate Director, Biostatistics and Programming will develop/QC all dataset/TFLs specifications to ensure that statistical programming elements align with CDISC’s overall requirements and follow general GCP and regulatory requirements/guidelines. This position will serve as a Programming Lead and represent Clinical and Statistical Programming in meetings with internal/external vendors and cross-functional project teams. The Associate Director, Biostatistics and Programming will act as a subject matter expert (SME) to all other Statistical Programmers and is an expert in comprehensively integrating statistical concepts with SAS Programming most efficiently and effectively. The Associate Director, Biostatistics and Programming must have oncology experience and can program/QC all efficacy endpoints which require advanced survival analyses, such as LIFETEST, PHREG, Bayesian statistics, and simulation used for power/sample size calculated using programming specifications provided by statisticians. This is a remote-based position located in the United States.
Responsibilities:

• Develop and QC programming specifications for SAS datasets (ADaM/SDTM/Derived)
• Develop and QC programming specifications for TFLs based on SAP
• Independently develop and QC programs that generate SAS datasets/TFLs based on programming specs.
• Supervise/manage external vendors and contract programmers
• Oversee progress of programming activities and control the timelines/quality of programming-related activities
• Review, maintain, and approve protocol specific documents related to programming
• Provide guidance and mentoring to peer and junior-level Programmers
• Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies
• Contribute ideas and thoughts towards the optimization of standard operating procedures
• Lead team meetings when appropriate
  

Requirements

• Bachelor’s degree with 12 years; Master’s degree with 8 years; or PhD with 5 year’s experience in Biostatistics, Statistics, or another related discipline. Proven management experience demonstrating business acumen, developing and delivering functional/department goals, delivering results, championing innovation, coaching and developing subordinates including remote and cross-functional teams
• Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
• Proven ability to develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs
• Expertise in using SAS/Base, SAS/Macro, SAS/STAT
• Knowledge of SAS/Graph and SAS/SQL
• Knowledge of SAS Macros
• Independently and collaboratively resolve problems
• Clearly communicate processes and standards with management and team members
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion
  

The anticipated annual base salary range for this role is $160,000 to $195,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.