DescriptionSummary
The
Senior Statistical Programmer Analyst will be responsible for support the submission readiness of study data packages per CDISC standards and FDA guidance, planning, execution, and quality of statistical analyses, and statistical programming infrastructure. This position will report into Head of Statistical Programming and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members. Demonstrated ability to prioritize work and to effectively communicate and collaborate with key stakeholders both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must.
This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will be highly experienced technical SAS programmer/developer with an in-depth understanding of clinical and/or statistical programming processes, tools, systems, and strong communication skills.
Responsibilities
- Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.
- Adopts strategic approach to producing and prioritizing analytical deliverables which includes study level or integrated analysis for safety signal detection or other business needs.
- Work with data management to review case report forms, database specifications, and data transfer specifications
- Manage on-time and quality delivery of CRO-generated analyses results.
- Solid, demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM) as well as health authority reporting requirements.
- In-depth knowledge of data standards and demonstrated experience in the handling non-CRF data including proven ability to work with diverse data types.
- Responsible for creating/reviewing SDTM/ADaM mapping specifications.
- Generates or validates SDTM domains, ADaM datasets, reviewer's guide, and define.xml files.
- Generates or validates TFLs to support the statistical analysis of data for clinical studies, regulatory submissions, and publications such as CSR, DSUR, IB, publications, etc.
Qualifications
- Bachelor's or Master's degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience
- Minimum 8+ years programming experience with growing responsibility in biotechnology or pharmaceutical clinical trial environment.
- Experience in software development and testing (e.g., SAS Macros tools, R functions/packages, Unix scripts etc).
- Experts in developing applications using various technical stacks not limited to SAS, R and/or Python.
- Solid understanding of industry standards such as CDISC, specifically SDTM and controlled terminology and/or ADaM.
- Proven ability to translate sophisticated problems into clear and concise programming code/tools.
- Basic Project management skills and experience.
- Solid understanding of programming practices (including tools and processes), relevant health authority guidelines, such as (e.g., ICH-GCP, 21 CFR Part 11), and relevant clinical R&D concepts.
- Demonstrated strong written, verbal communication skills, ability to manage conflicting demands and priorities and to negotiate successfully.
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