Senior Statistical Programmer Analyst Contractor - Remote in US
Arcus Biosciences · United States
- Hybrid
- Full-time
- $150,000 / year
- United States
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Job highlights
- Support study data packages for regulatory submissions.
- Plan and execute statistical analyses and programming.
- Collaborate with internal and external stakeholders.
- Utilize SAS, R, and Python for data analysis.
- Ensure quality delivery of analysis results.
About the role
Senior Statistical Programmer Analyst Contractor - Remote in US
Summary
The Senior Statistical Programmer Analyst Contractor will be responsible for supporting 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 the 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 a 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 a 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 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.
- 8+ years of programming experience with growing responsibility in a 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.
Key skills/competency
- Statistical Programming
- CDISC Standards (SDTM, ADaM)
- SAS Programming
- R Programming
- Python Programming
- Clinical Trial Data
- Data Management
- Regulatory Submissions
- Biostatistics
- Software Development
Skills & topics
- Senior Statistical Programmer Analyst
- Statistical Programming
- SAS
- R
- Python
- CDISC
- SDTM
- ADaM
- Clinical Trials
- Biotechnology
How to get hired
- Tailor your resume: Highlight SAS, R, Python, CDISC, and clinical trial programming experience.
- Showcase expertise: Emphasize your ability to translate complex problems into code and manage priorities.
- Prepare for technical questions: Be ready to discuss SAS Macros, R packages, and Unix scripting.
- Understand industry standards: Familiarize yourself with CDASH, CDISC (SDTM, ADaM), ICH-GCP, and 21 CFR Part 11.
- Demonstrate communication skills: Prepare examples of successful collaboration and negotiation with diverse teams.
Technical preparation
Master SAS, R, and Python programming.,Practice writing SAS Macros and R packages.,Review CDISC SDTM and ADaM standards.,Understand ICH-GCP and 21 CFR Part 11.
Behavioral questions
Describe a complex problem you solved with code.,How do you manage competing project priorities?,Give an example of effective stakeholder collaboration.,How do you ensure quality in your programming?
Frequently asked questions
- What is the required educational background for the Senior Statistical Programmer Analyst Contractor role at Arcus Biosciences?
- Arcus Biosciences requires a Bachelor's or Master's degree in a data science field such as statistics, mathematics, epidemiology, computer science, bioinformatics, or a related area with equivalent experience for this role.
- What programming languages and tools are essential for this Senior Statistical Programmer Analyst Contractor position?
- Expertise in SAS is crucial, along with strong development skills in R and/or Python. Experience with SAS Macros tools, R functions/packages, and Unix scripts is also highly valued.
- How important are CDISC data standards for this role at Arcus Biosciences?
- A solid understanding and demonstrated experience with CDISC data standards, specifically SDTM and ADaM, are essential. This includes knowledge of controlled terminology and the ability to create/review mapping specifications.
- What is the expected level of experience for the Senior Statistical Programmer Analyst Contractor?
- The role requires a minimum of 8 years of programming experience with increasing responsibility, specifically within the biotechnology or pharmaceutical clinical trial environment.
- Does Arcus Biosciences require specific knowledge of health authority guidelines for this contractor position?
- Yes, a solid understanding of relevant health authority guidelines, such as ICH-GCP and 21 CFR Part 11, is expected for this Senior Statistical Programmer Analyst Contractor role.
- What type of projects can I expect to work on as a Senior Statistical Programmer Analyst Contractor at Arcus Biosciences?
- You will develop specifications and programs for internal data reviews, publications, exploratory analyses, post-hoc analyses, and regulatory reviews, supporting study-level and integrated analyses.
- How does Arcus Biosciences handle the management of outsourced statistical programming work?
- The Senior Statistical Programmer Analyst Contractor is responsible for managing the on-time and quality delivery of analyses results generated by CROs.
- What are the key soft skills required for this role?
- Strong written and verbal communication skills are essential. The ability to prioritize work, manage conflicting demands, negotiate successfully, and collaborate effectively with diverse stakeholders is also critical.