About this opportunity
Run my Accounts AG lists this Associate Director of Statistical Programming opportunity in seattle, Washington. Review the employer’s description below for duties, qualifications and application requirements.
Job description
About Us
Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas extend beyond pain and inflammatory gastrointestinal disease, where Eupraxia is currently developing advanced treatments, to applications in oncology, infectious disease and other critical disease areas.
We are looking for people who would like to work in a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who are eligible to work in the United States.
Scope
The Associate Director of Statistical Programming provides strategic and operational leadership for all statistical programming activities within and across clinical development programs. This role is responsible for ensuring timelines and the quality standards for programming deliverables are met. They will serve as the primary statistical programming representative in cross-functional teams and lead programming related activities for regulatory submissions (INDs, IBs NDA/BLAs, etc.), clinical study reports, abstracts, and publications. This role may supervise junior statistical programmers.
Reports to
VP of Biometrics and Data Management
Location
Kirkland, WA (hybrid work environment)
Key responsibilities and duties
Lead statistical programming activities across one or more clinical development programs
Program and validate deliverables for interim and final analyses, publications, abstracts, CSRs, and regulatory submissions
Collaborate with study biostatisticians to develop and implement TLF programming for statistical analysis plans
Assist data management in the development and programming of non-system edit checks for clinical trial data
Develop and maintain the statistical programming environment for biometrics
Provide hands‑on oversight of CROs and external statistical programming groups to ensure quality standards and timelines are met for programming related deliverables
Develop SOPs for statistical programming function
Education, qualifications and work experience
Bachelor’s degree or higher
15+ years of biotech/pharma experience as a statistical programmer
Expert level knowledge of CDISC standards (SDTM, ADaM) and SAS
Experience preparing study data and output for regulatory submissions
Demonstrated experience supporting pivotal and registrational clinical trials
Strong CRO and vendor oversight experience
Track record of delivering high-quality programming related deliverables
Strong experience with Pinnacle 21
Additional attributes
Knowledge of R a plus
Salary Range
$160,000 to $190,000 depending on education and relevant experience.
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Worksite address
seattle, WA, 98127, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.