Senior Manager of Biostatistics

2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Digital Prospectors Position: Senior Manager of Biostatistics Location: Remote Length: 6+ months to start Job Description: We’re seeking an experienced Senior Manager of Biostatistics to provide strategic statistical leadership and hands-on analytical support across clinical development programs. This role offers the opportunity to work cross-functionally on the design, execution, and interpretation of clinical studies that drive impactful decisions in drug development. Essential Duties and Responsibilities: Serve as the statistical lead for clinical studies, ensuring scientific rigor and data integrity throughout all phases. Provide expertise in study design, sample size determination, and development of statistical analysis plans (SAPs), DMC charters, and randomization files. Develop and review table, figure, and listing (TFL) specifications and collaborate on CRF and study documentation review. Partner closely with biometrics and cross-functional teams to meet data analysis and reporting milestones. Independently conduct statistical analyses and propose innovative methods to enhance study efficiency and interpretability. Contribute to the advancement of internal statistical methodologies and standards. Participate in preparation and review of regulatory submissions and scientific publications. Qualifications: PhD in Statistics, Biostatistics, or a related field with 3+ years of post-graduate experience in clinical trials; or Master’s degree with 6+ years of relevant industry experience. Proven experience supporting late-phase clinical trials, including regulatory submissions (e.g., NDA/BLA/MAA). Demonstrated ability to lead statistical strategy and collaborate effectively within cross-functional teams. Hands-on experience with authoring SAPs and TFL specifications. Strong understanding of ICH, FDA, and EMA statistical guidelines. Skilled in SAS and R programming; familiarity with CDISC standards (SDTM, ADaM, and controlled terminology) preferred. Highly organized and detail-oriented with strong problem-solving and prioritization skills. Background Check and EEO 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 ( 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! Job #18051 Seniority level Mid-Senior level Employment type Contract Job function Science and Consulting Industries Staffing and Recruiting and Biotechnology Research Referrals increase your chances of interviewing at Digital Prospectors by 2x Get notified about new Manager Biostatistics jobs in Massachusetts, United States . Associate Director, Biostatistics (late-stage) Cambridge, MA $143,250 - $210,100 1 week ago Massachusetts, United States $128,000 - $140,000 3 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Digital Prospectors