Associate Director, Statistical Programming / Principal Statistical Programmer

Wave Life Sciences • Lexington, MA

2d • $141,000 - $191,000

About The Position

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a clinical program in obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Description: The Associate Director, Statistical Programming / Principal Statistical Programmer, will lead and oversee the statistical programming for clinical trials at Wave Life Sciences including the application of data standards; specification, production and QC of analysis datasets, tables, listings and figures; generation of electronic submission components (define.xml and XPTs); and management and execution of ad hoc programming requests. A demonstrated ability in producing high quality and regulatory compliant statistical deliverables for regulatory submissions and publications is required. The successful candidate must possess extensive experience and proven skills with SAS in a statistical computing environment as well as the ability to interact and collaborate with a cross-functional clinical development team.

Requirements

• Bachelor’s degree required.
• 7+ years of experience in SAS programming
• Expert proficiency, complete knowledge and understanding of statistical programming processes, procedures, and roles
• Experience with CDISC SDTM and ADaM models including transforming raw database files while adhering to those standards
• Demonstrated knowledge of the lifecycle of clinical data projects
• Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment with a demonstrated mastery of SAS/STAT procedures
• Experience in organizing BLA, NDA/s NDA regulatory submissions
• Extensive experience and proven ability in the use of SAS within a statistical computing environment to develop and validate statistical deliverables
• Demonstrated knowledge of regulatory requirements for statistical programming deliverables and the regulatory submission process
• Experience in developing and implementing SOPs
• Possess a thorough knowledge of medical terminology and the clinical trial process including knowledge of biostatistics, data management, pharmacovigilance and clinical operations functions
• Proficient in developing requests for proposals for external vendor contracts and in evaluating external vendor capabilities
• Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company
• Demonstrate effective time management and organizational skills including the ability to work under deadlines and on multiple projects simultaneously
• Previous SAS programming experience, including SAS STAT, GRAPH and MACRO
• Extensive knowledge of drug development process and clinical trials
• Excellent organizational, interpersonal, and communication skills
• Ability to moderate to large volume of complex tasks with minimal supervision
• Able to handle ad-hoc requests with minimal guidance

Nice To Haves

• Master’s degree or PhD in biostatistics (or related discipline) preferred

Responsibilities

• Manage and oversee vendors, contractors and internal personnel to accomplish statistical programming activities for clinical trials.
• Provide accountability for external vendor timeline management
• Author CDISC-compliant dataset specifications including definitions and documentation of endpoint algorithm programming
• Develop and validate programs to analyze clinical trial data and to report results in tables, listings and figures
• Manage the end-to-end programming of deliverables from CRF collection through electronic submission including preparation of electronic submissions components
• Contribute to the development, implementation, and versioning of statistical programming practices and standards
• Review, and comment on CRFs, annotated CRFs, and edit checks and related documents
• Verify program consistency and usage of data, analysis and submission standards across clinical trials
• Collaborate with biostatistics, data management, pharmacovigilance and clinical to provide programming support

Benefits

• company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees