Statistical Programming and Biostatistics Trainee

Job Posted 11/22/2024
Veramed
Boston, MA
United States
Category
Job Description

Early Career Opportunity in Drug Development Data Science and Analytics


Company: BioPier, LLC. (a Veramed Company)

Location: Burlington, MA

Position: Statistical Programming and Biostatistics

Type: Full-time


Brief Description: BioPier, LLC., a Veramed company, is seeking highly motivated, inquisitive, coachable and skilled programmers. We prefer a master’s degree or higher in STEM disciplines, who have strong programming, analytical, and data science skills and are looking to launch their careers in the fast-growing field of drug development and clinical data science. This position offers a unique opportunity to work alongside the talented BioPier team, receive hands-on training, and contribute to high-impact projects in the clinical and biostatistics domain. This is a paid, full-time benefit eligible position.


Position Responsibilities:


Statistical Programming:

· Conduct Phase I-IV Clinical Study Reports (CSRs) to evaluate study safety and efficacy

· Work on data science and standardization projects, including CDASH, CDISC SDTM, and ADaM

· Compile Integrated Summaries of Safety and Efficacy for drug approval

· Prepare regulatory patient safety reports (PBRER, DSUR, PSUR, SWG, SRT, EU-RMP, DMC, IB)

· Support Independent Data Monitoring Committees and create patient profiles and narratives


Biostatistics Services:

· Provide statistical input in clinical trial design and protocol development

· Perform power and sample size calculations

· Develop randomization schemes and conduct exploratory data analysis

· Draft Statistical Analysis Plans (SAP) and design tables, figures, and listing shells

· Contribute statistical expertise to Clinical Study Reports and regulatory presentations


Qualifications:

· Masters degree in any STEM field with a strong analytical, programming, and data science foundation

· Proficient SaS programming required

· Ability to quickly learn and adapt to complex biostatistics and clinical data science tasks

· Motivation to excel in a fast-paced, collaborative environment


BioPier offers a supportive, dynamic environment where recent graduates can build foundational expertise and make a meaningful impact in healthcare. Visit veramedinc.com to learn more about our team and accomplishments.