Cdisc Part Time Jobs (NOW HIRING)

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 1–3: 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 We're 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 Master's degree (MS) in Statistics or Biostatistics

What You'll 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.