Posted 21 days ago
Statistical ProgrammerSystimmune · Princeton
Statistical Programmer
PrincetonOn-siteFull-time$80k–$100k
AI Summary
Supports clinical trial statistical programming by generating and validating SDTM/ADaM datasets, define.xml, and TFLs using SAS, in collaboration with biostatisticians and study teams. Hybrid role based in Princeton, NJ.
About this role
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. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
The Statistical Programmer will support statistical programming activities for clinical trials, including generating SDTM/ADaM datasets, tables, figures, and listings (TFLs). This role is ideal for someone early in their career who is eager to learn and grow in a fast-paced biotech environment with exposure to end-to-end clinical development.
This position is Hybrid (3 days onsite minimum) in our Princeton, NJ office.
Responsibilities
The Statistical Programmer will support statistical programming activities for clinical trials, including generating SDTM/ADaM datasets, tables, figures, and listings (TFLs). This role is ideal for someone early in their career who is eager to learn and grow in a fast-paced biotech environment with exposure to end-to-end clinical development.
This position is Hybrid (3 days onsite minimum) in our Princeton, NJ office.
Responsibilities
- 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.
Qualifications
- 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.
Compensation and Benefits:
The expected base salary range for this position is $80,000 - $100,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
Skills
ACRFADaMCDISCClinical Trial DesignDefine.xmlRegulatory SubmissionsSAP ReviewSASSAS MacrosSDTMTFLs
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