Job Details

The Associate Director, Statistical Programming will be the Lead Statistical Programmer on multiple complex projects or products in the Statistical Programming function, including NDA and other submissions to regulatory agencies. This position also manages programming teams and provides statistical programming support for clinical study reports, integrated summary of safety (ISS), integrated summary of efficacy (ISE), and post-marketing analysis needs. The individual will build and define Elevar's internal statistical programming environment and processes. The individual will also work closely with Statisticians to ensure that deliverables provided by internal resources or outside providers are accurate and aligned with sponsor standards. This is a remote-based position located in the United States.

Responsibilities:

• Provide functional expertise and leadership to clinical project teams to lead statistical programming teams and support the development, regulatory approval, and market acceptance of Elevar products
• This position is primarily responsible for the design, development, and implementation of technical solutions for integrating, analyzing, and reporting clinical data
• Drive the development and implementation of innovative strategies and technologies for clinical trial programming
• Develop collaborative relationships and works effectively within Biometrics, with external vendors, and members of cross-functional development teams
• Provide comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices
• This position is responsible for validating programming results generated by external vendors, as well as ad hoc analysis production in-house
• Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with pre-defined specifications and standards
• Lead the electronic submission preparation and review; develop unambiguous and robust programming specifications
• Act as an extended member of the Statistical Programming Leadership Team in sharing and building up the line function vision

Requirements

• Bachelor's degree with 12 years; Master's degree with 8 years; or PhD with 5 year's experience in Biostatistics, Statistics. 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.
• Master's Degree in Statistics, Biostatistics, Mathematics
• At least 8 years Programming experience in industry including support of significant regulatory filings
• Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
• SAS programming experience in oncology studies
• Strong collaborative skills and ability to work with a cross-functional team
• In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
• Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g., MS office, XML, Pinnacle 21)
• Demonstrated ability in processing of upstream data (e.g., multiple data forms, workflows, EDC, SDTM, ADaM); demonstrated ability in providing deliverables to meet downstream requirements
• Demonstrated ability to work in a team environment with clinical 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.

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