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 full-time onsite at our Bothell, WA location. We will consider candidates for our Princeton, NJ location on a case by case basis.
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 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.
