New

Biostatistics Consultant

Digital Prospectors
United States, Massachusetts, Woburn
Sep 09, 2025
Position:Biostatistics Consultant Location:Dallas, TX (Remote) Length:6+ months W2 Candidates Only, No C2C Job Description:* Our client is seeking an experienced Biostatistics Consultant to join their team and provide statistical leadership and expertise in support of clinical research studies. In this role, you will act as a statistical study lead, guiding the design, analysis, and interpretation of clinical trial data. You will collaborate with cross-functional teams to ensure high-quality statistical input across study planning, execution, and reporting, while also contributing to the development of advanced methodologies and regulatory submissions. This position is ideal for a highly motivated professional with a strong background in biostatistics who is looking to make an impact in a dynamic, collaborative environment. Essential Duties and Responsibilities (but not limited to): Serve as the statistical lead at the study level, ensuring scientific and statistical integrity. Provide input on study design, including sample size determination, statistical sections of protocols, and SAP development. Review randomization files, case report forms (CRFs), and other study documentation. Develop TFL shells and specifications; review and validate outputs. Conduct statistical analyses, evaluate data, and propose novel methodologies to enhance study efficiency and sensitivity. Collaborate closely with biometrics teams and cross-functional stakeholders to achieve study deliverables and timelines. Contribute to the preparation of regulatory submissions and scientific publications. Support the development of standards and research in advanced statistical methodologies. Qualifications: PhD in Statistics or Biostatistics with 3+ years of experience in clinical trials within the pharmaceutical or biotechnology industry or Master's degree with 6+ years of post-graduate experience. Proven experience supporting NDA/BLA/MAA activities; regulatory interaction preferred. Ability to serve as study lead statistician and contribute to strategy in cross-functional discussions. Hands-on experience with authoring SAPs and TFL specifications. Familiarity with ICH guidelines, FDA/EMA/other regulatory requirements. Strong knowledge of mathematical and statistical principles. Proficiency in SAS and R; experience with CDISC standards (SDTM, ADaM, controlled terminologies) preferred. Excellent problem-solving, organizational, and communication skills with the ability to manage multiple priorities effectively. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment. Come see why DPC has achieved: 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor. Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine. As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today! www.LoveYourJob.com