Penfield Search Partners
Contact: Linda Aronova 646.882.9021 firstname.lastname@example.org
Job Description: In this role, your work will help the advancement of new antibody-drug conjugate (ADC) therapies to treat patients fighting cancer, including ovarian cancer and non-small cell lung cancer. Specifically, you will generate output which will have high visibility to end-user decision makers and be used to help drive the path forward for the companys technologies. You will be immersed in a learning and highly collaborative organization, with a need to bring an open mind and an interest in mastering this new therapeutic space at a rapid pace. If you are currently working at a CRO and have been wanting to make the move to the Sponsor side, this may be a great opportunity for you.
You will assist company with building processes that drive innovation, teamwork, and efficiency in support of our clinical pipeline. You will also form working relationships with members of the Clinical Data Science, Clinical Operations, Translational Medicine, Clinical Pharmacology, and Biology Research teams and have the opportunity to hone your skills in these areas of research and data analysis including drug safety surveillance, translational medicine genetic data review techniques, pharmacokinetics and pharmacodynamics. You will be reporting to the Vice President of Biostatistics.
To be successful, you will previously have utilized SAS to generate output used for data modeling, clinical trial reports and regulatory submission packages (i.e., tables, listing, figures, as well as SDTM, SEND, and ADaM datasets) within the pharmaceutical industry. Experience in the oncology therapeutic space is a plus. A solid understanding of the CDISC SDTM and ADaM IGs is required.
How do you know if youre the right fit?
If you are a highly self-motivated, driven individual who is articulate and enjoys the challenges and opportunities available in a growing, fast-paced and transforming organization, such as solving complex SAS programming tasks, this will be an opportunity for you to apply yourself, learn and deliver.
Your experience will span along the range of the following responsibilities within the oncology therapeutic space:
- Write SAS programs to generate tables, listings, and figures.
- Build SEND, SDTM and ADaM datasets from clinical databases following CDISC guidelines.
- Create mapping specifications for derived datasets.
- Develop SAS macros, templates and utilities for data cleaning and reporting.
- Implement analyses specified in Statistical Analysis Plans.
- Utilize SAS to fit statistical models (i.e., PROC REG, PROC IML and PROC GLM).
- Validate SAS programs used to create output in a regulated environment.
- Work in tandem with Biostatisticians and Data Managers on various clinical projects.
- This is typically a role best suited for those with a Bachelor or Masters level degree in statistics/biostatistics, mathematics, computer science or engineering who possess at least 5+ years of pharmaceutical/biotechnology/CRO experience.