Position:Senior Manager, Biostatistics
Location:Great Boston, MA (Remote)
Length:6+ months
*W2 Candidates Only, No C2C
Job Description:
Our client is seeking a highly skilled Senior Manager of Biostatistics to join their team. This role offers the opportunity to make a significant impact on the design, analysis, and interpretation of clinical trial data for innovative therapies. You will work closely with cross-functional teams, ensuring statistical rigor and compliance with regulatory standards, while contributing to strategic decision-making in a dynamic and collaborative environment.
Essential Duties and Responsibilities (but not limited to):
- Provide statistical expertise at the study level, including study design, sample size determination, and authoring or reviewing statistical sections in protocols, SAPs, and DMC charters.
- Create and review study randomization files, develop TFL shells and specifications, and review CRFs and other study documentation.
- Actively participate in study-related and cross-functional team meetings.
- Ensure statistical integrity of deliverables and provide scientifically sound input to meet project objectives and regulatory requirements.
- Independently conduct analyses and propose innovative statistical methodologies to enhance study efficiency and sensitivity.
- Contribute to the development of internal standards and advanced statistical methods.
- Author and review regulatory documents and support scientific publications.
Qualifications:
- Ph.D. in Statistics or Biostatistics with 5+ years of post-graduate experience in clinical trials (or 8+ years with a Master's degree).
- Proven experience as a study lead statistician and key contributor in NDA/BLA/MAA submissions, including regulatory interactions.
- Strong background in authoring SAPs and TFL specifications.
- Deep understanding of ICH guidelines and regulatory authority guidance (FDA, EMA, etc.).
- Solid knowledge of mathematical and statistical principles with a focus on problem-solving and prioritization.
- Proficient in SAS and R, with familiarity in CDISC standards (SDTM, ADaM, and controlled terminologies).
- Highly detail-oriented with excellent organizational skills and the ability to manage multiple tasks in alignment with company timelines.
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.
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- 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.
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Digital Prospectors
Jul 16, 2025