Endpoint Clinical · 4 days ago
Biostatistician
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Responsibilities
Provide statistical expertise in the design and analysis of clinical trials.
Develop and author SAPs for assigned projects.
Review clinical trial protocols to ensure statistical soundness and provide feedback to study teams.
Author the protocol statistical sections and generate SAPs and study randomization.
Analyze clinical trial data using advanced statistical techniques and software.
Collaborate closely with Statistical Programmers to review and validate data sets, tables, listings, and other statistical outputs.
Review and sign-off on relevant study documents and data management and programming deliverables.
Provide programming support to supplemental or exploratory analyses any other internal and external ad-hoc requests.
Stay current with relevant regulatory guidelines and ensure compliance in all statistical deliverables.
Represent the biostatistics function on project teams and in cross-functional meetings.
Perform other duties as required and assigned.
Qualification
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Required
Master’s or PhD in Statistics, Biostatistics, or a related field is required.
Bachelor’s degree with substantial working experience in biostatistics will be considered.
2+ years of biostatistics experience, preferably in clinical trials.
Proficiency in statistical software such as SAS, R, or Python required.
Strong statistical knowledge, including experience with survival analysis, mixed models, and longitudinal data analysis.
Excellent problem-solving abilities and attention to detail.
Demonstrated ability to work independently and within cross-functional teams.
Strong written and verbal communication skills, with the ability to clearly present statistical findings.
Familiarity with regulatory requirements for clinical trial data.
Preferred
Experience in the life sciences, regulatory environments, and knowledge of 21 CFR Part 11 and GxP is highly preferred.
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(K)
Paid time off (PTO) or Flexible time off (FTO)
Company bonus where applicable
Company
Endpoint Clinical
Endpoint Clinical designs, engineers, and tests interactive response technology platforms that enables data access through phones.
H1B Sponsorship
Endpoint Clinical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (16)
2020 (11)
Funding
Current Stage
Late StageTotal Funding
$1.7M2010-03-01Debt Financing· $1.7M
Recent News
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