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Associate Director, Statistical Programming
Our client 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 our client’s 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 our client is currently developing advanced treatments, to applications in oncology, infectious disease and other critical disease areas.
Our client is currently in a Phase 1b/2 trial for the treatment of eosinophilic esophagitis (EoE). This drug is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Our client also recently completed a Phase 2b clinical trial for the treatment of pain due to knee osteoarthritis. This trial successfully met its primary endpoint and three of the four secondary endpoints. In addition, our client is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. Our client is 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)
The precision of our client’s 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 our client is currently developing advanced treatments, to applications in oncology, infectious disease and other critical disease areas.
Our client is currently in a Phase 1b/2 trial for the treatment of eosinophilic esophagitis (EoE). This drug is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Our client also recently completed a Phase 2b clinical trial for the treatment of pain due to knee osteoarthritis. This trial successfully met its primary endpoint and three of the four secondary endpoints. In addition, our client is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. Our client is 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
- 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
- Knowledge of R a plus