Statistical Programmer
SystImmune
- Pay
- $80K to $100K
- a year
- Location
- Princeton, NJ
- Work style
- Hybrid
- 3 days in office
- Posted
- Oct 18
- 1 day ago
Career path
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About the company
SystImmune
Biotechnology · 11 to 50 employees
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development.
What you'll do
- Collaborate with biostatisticians and cross-functional study team members to deliver statistical analysis and reporting outputs in line with project timelines.
- Review study documents including statistical analysis plans (SAPs), CRFs, database specifications, and data transfer specifications.
- Create and/or review SDTM/ADaM mapping specifications and annotated CRFs (aCRFs).
- Generate and/or validate SDTM and ADaM datasets, including associated Define.xml and reviewer’s guides.
- Develop and validate tables, figures, and listings (TFLs) to support clinical study analyses, regulatory submissions, conferences, and publications.
- Assess the quality, integrity, and consistency of analysis datasets, including cross-study analyses where applicable.
- Develop SAS programs and macros to automate dataset generation and reporting deliverables.
- Contribute to process improvements and enhancements of the statistical programming environment.
- Participate in study team meetings and representing statistical programming in cross-functional discussions.
- Apply knowledge of clinical trial design, CDISC standards, and regulatory requirements while producing analysis datasets and outputs in compliance with SOPs and industry standards.
What you need
- Master’s degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific discipline, with 0–2 years of experience in statistical programming within the pharmaceutical/biotech industry or a CRO.
- Proficiency in SAS programming, preferably with experience in a clinical trial environment.
- Working knowledge of CDISC standards (SDTM and ADaM).
- Hands-on experience in developing and validating SDTM and ADaM datasets, as well as statistical outputs (tables, figures, and listings).
- Prior experience or exposure to oncology studies is preferred.
- Strong analytical, problem-solving, and organizational skills.
- Effective communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
- Education: a postgraduate degree
Key skills
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Perks
- 100% paid employee premiums
- medical/dental/vision
- STD
- LTD
- 401(k) plan
- 15 PTO days
- sick leave
- 11 paid holidays
See full description on company page, apply now