Senior Manager, Biostatistics
Bedford, MA
Job Type: Contract | Recruiter: Jaime Gunning | Phone: 617.215.7066
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.
- 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.
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.
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