Associate Diirector of Statistics
Aequor JD ·www.aequor.com
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Job Description
Responsibilities:
Ph.D. with 8 years of experience or MS with 11 years of drug development experience .
Please have experience with adaptive design, interaction with Regulatory Affairs, have hands on skills in programming and be able to think strategically.
Responsibilities:
- Lead late phase project and regulatory submissions. Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
- Define statistical strategy and ensure appropriate statistical methodologies applied to study design and da Close ta analysis for clinical trials.
- Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
- Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
- Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
- Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
- Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP.
- Support or lead improvement initiatives within the department, organization and/or pharma industry.
- Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.
Ph.D. with 8 years of experience or MS with 11 years of drug development experience .
Please have experience with adaptive design, interaction with Regulatory Affairs, have hands on skills in programming and be able to think strategically.
Frequently asked questions
Who is hiring for the Associate Diirector of Statistics role?
Aequor JD is hiring for the Associate Diirector of Statistics position, a Shazamme client. Apply directly on the employer's career site.
Where is the Associate Diirector of Statistics job located?
The Associate Diirector of Statistics role with Aequor JD is based in King of Prussia, PA, US.
What does the Associate Diirector of Statistics role pay?
Aequor JD lists the Associate Diirector of Statistics role at USD 175,000–200,000 per year.
Is the Associate Diirector of Statistics role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Associate Diirector of Statistics role?
The Associate Diirector of Statistics position is aimed at junior-level candidates.
How do I apply for the Associate Diirector of Statistics role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.