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in Rockville, MD
Biostatistician II
•9 days ago
Estimated Pay | $56 per hour |
---|---|
Hours | Full-time, Part-time |
Location | Rockville, Maryland |
Compare Pay
Estimated Pay We estimate that this job pays $56.49 per hour based on our data.
$37.93
$56.49
$76.87
About this job
Job Description
Job Description
Summary:
Our client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with an experienced Biostatistician to drive projects and process improvement activities across the organization.
Responsibilities:
- Provides statistical input to clinical development plans (CDP), including study design, sample size, primary and secondary endpoints, and statistical analysis method by working together with clinical pharmacological and other functions
- Support protocol development on early phase studies to make sure clear description of clinical study design, randomization, statistical analysis methodology and key statistical activities in protocol.
- Develops a detailed Statistical Analysis Plan (SAP) to document technical considerations and corresponding mock tables, figures, and listings.
- Support final tables, figures, and listings development for final study report (CSR), publication and regulatory submissions.
- Reviews final statistical tables, listings, and figures
- Provides specs to SAS programmers for generating analysis datasets.
- Produce Randomization codes.
- Coordinate with data management to Review CRF and IDRP, review and approve database structure and edit-check specifications.
- Proactive and timely communication with study team on stats activities and its progress per planned timeline by working with Clinical management.
Requirement:
- Masters or PhD in Statistics or Biostatistics
- Minimum of 3 years of experience in the pharmaceutical industry.
- In-depth knowledge of statistical principles, applications, and SAS programming software.
- Awareness of new drug developments and statistical methodologies in the business.
- Working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions.
Additional Notes
- 12+ month contract
- Remote - EST timezone.
- Healthcare Benefits Available
- Start ASAP
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