Associate Director of Statistical Programming

Run my Accounts AG; Seattle (WA); Hybrid; USD 160,000 - 190,000; Full time

Job summary

Eupraxia in Kirkland, WA, is seeking an Associate Director of Statistical Programming to lead programming activities across clinical programs and ensure timely, high-quality deliverables for regulatory submissions. You will work cross-functionally with biostatisticians and data management in a hybrid environment.

The role requires deep CDISC/SAS expertise, 15+ years in biotech/pharma programming, and experience overseeing CROs, with a focus on delivering pivotal trial data for IND/ NDA

Qualifications

• Bachelor’s degree or higher in a scientific field.
• 15+ years biotech/pharma experience as a statistical programmer.
• Expert knowledge of CDISC SDTM/ADaM and SAS.
• Experience preparing study data and output for regulatory submissions.
• Strong CRO and vendor oversight experience.
• Track record delivering high-quality programming deliverables.
• Familiarity with Pinnacle 21.

Responsibilities

• Lead statistical programming activities across one or more clinical development programs.
• Program and validate deliverables for interim and final analyses, publications, CSR, and regulatory submissions.
• Collaborate with study biostatisticians to develop and implement TLF programming for SAPs.
• Assist data management in the development and programming of non-system edit checks for 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 and timelines.
• Develop SOPs for statistical programming function.

Skills

Statistical programming

Leadership

Regulatory collaboration

Education

Bachelor’s degree or higher

15+ years biotech/pharma statistical programming

Tools

SAS

CDISC SDTM/ADaM

Pinnacle 21

Vendor CRO oversight

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.