Job description

Job Title: Associate Director of Statistics
Locations: King of Prussia, PA - required Onsite once a week
Salary: $170,000 – $200,000

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 data 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.

Qualifications
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

Job Type: Full-time

Pay: $170,000.00 - $200,000.00 per year

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Master's (Preferred)

Experience:

• programming: 8 years (Preferred)
• drug development: 8 years (Preferred)
• regulatory submissions: 8 years (Preferred)

Work Location: In person

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