Remote Biostatistics Consultant – Oncology Program
Newark, DE - USA
Job Summary
Position Overview
We are seeking a highly skilled Biostatistics Consultant to support critical statistical deliverables within our oncology program (SMPA). In this role you will serve as the primary biostatistician for assigned clinical studies driving closeout activities validating data quality and ensuring all statistical outputs are scientifically rigorous and publication-ready.
You will work at the intersection of clinical data and medical communications collaborating closely with the Medical Strategy Lead and Publications Specialist to turn complex clinical trial data into high-impact accurate scientific content
Engagement & Capacity Logistics
This is a part-time consulting engagement designed to scale alongside our trial closeout and publication milestones:
Months 13: Approximately 10 to 15 hours per week to support peak closeout and analysis validation activities.
Remaining Term: Scales back to 5 to 10 hours per week for ongoing publication support and targeted statistical advisory until the engagement ends.
What Were Looking For (Required & Elite Qualifications)
To land this role and help us maintain an exceptionally high bar for scientific validity you must possess the following elite skills and background:
Professional Experience: A minimum of 3 years of post-PhD experience or 5 years of post-MS experience directly managing and executing statistical analyses within clinical trials.
Oncology Expertise: Deep in-depth knowledge of statistical principles up-to-date methodologies and complex design rules explicitly applied within oncology clinical trials.
Advanced Statistical Modeling: Direct hands-on experience utilizing Bayesian modeling and analysis alongside traditional frequentist statistical frameworks.
Software Mastery: Expert-level proficiency in statistical programming languages specifically SAS and R with a proven ability to independently guide validate and troubleshoot automated analyses.
CDISC Data Standards: Comprehensive experience working with and overseeing global clinical data standards specifically CDISC SDTM and ADaM including the meticulous development and quality control of data specifications.
Communication & Influence: Elite written and verbal communication skills with a demonstrable ability to clearly explain complex statistical designs decision rules and analysis plans to cross-functional medical teams.
Education: A PhD or Masters degree (MS) in Statistics or Biostatistics
What Youll Do
Lead Statistical Deliverables: Serve as the primary biostatistician for oncology clinical trials managing study closeout activities reviewing validating and executing complex statistical analyses.
Technical Guidance & Programming QC: Partner with and guide statistical programmers on developing SDTM/ADaM datasets and crafting comprehensive TLF (Tables Listings and Figures) specifications. Perform stringent quality control checks on all programming efforts.
Scientific Publication Support: Interpret complex statistical results and contribute directly to statistical methodologies text and data structures for scientific abstracts posters and manuscripts.
Cross-Functional Communication: Work closely with the Medical Strategy lead and publications specialists to address publication-related statistical questions. Clear up statistical ambiguity and present complex concepts plainly to both technical and non-technical stakeholders.
Rigorous Quality Control: Ensure the utmost accuracy and data integrity across all data-driven insights keeping analysis metrics strictly aligned with clinical trial protocols and compliance requirements.