Senior Manager of Biostatistics

Digital Prospectors

Massachusetts

Remote

USD 128,000 - 210,100

Full time

14 days+

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Benefits offered by this job

Competitive salary

Opportunity for impact on drug development

Job summary

A leading staffing firm is seeking a Senior Manager of Biostatistics to provide strategic leadership in clinical development. This remote role requires a PhD in Statistics or Biostatistics with at least 3 years of experience in clinical trials. Responsibilities include overseeing study design and contributing to regulatory submissions. The position is for 6+ months, ideal for candidates with strong analytical skills and expertise in SAS and R programming.

Qualifications

PhD in Statistics, Biostatistics, or related field with 3+ years post-graduate experience.
Experience supporting late-phase clinical trials including regulatory submissions.
Strong understanding of ICH, FDA, and EMA statistical guidelines.

Responsibilities

Serve as the statistical lead for clinical studies ensuring scientific rigor.
Contribute to regulatory submissions and scientific publications.
Develop and review statistical analysis plans.

Skills

SAS

R programming

Statistical strategy

Problem-solving

Collaboration

Education

PhD in Statistics or Biostatistics

Master's degree

Tools

CDISC standards

Job description

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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.

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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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Job #18051

Seniority level