Director of Statistics

Pharmapace, Inc.; San Diego (CA); On-site; USD 160,000 - 230,000; Full time

Benefits offered by this job

Stock options

401K plan with company match

Health/dental/vision insurances

Holiday/vacation benefits

Job summary

Pharmapace, Inc. in San Diego seeks a Director of Statistics to provide strategic statistical consulting across biotech and pharmaceutical client programs, oversee study design, regulatory submissions, and mentor statisticians.

You will lead projects, collaborate with cross-functional teams, develop analysis plans, supervise staff, and contribute to business proposals. Doctoral-level expertise and 10+ years of industry experience are required.

Qualifications

• Doctoral-level statistician with extensive experience in drug development.
• Strong grasp of regulatory submissions and study design.
• Proven ability to mentor statisticians and lead projects.

Responsibilities

• Provide statistical consulting for clinical study design and protocols.
• Develop analysis plans to support regulatory submissions.
• Prepare statistical reports and interpret results for submissions.
• Review clinical study reports and regulatory documents.
• Lead methodological research and stay current with drug development trends.
• Mentor statisticians to ensure timely, high-quality analyses.

Skills

Statistical methodologies

Regulatory knowledge

Leadership/mentoring

Communication

Education

Doctoral degree in Statistics, Biostatistics, or Mathematics

Tools

SAS

R

Job description

Pharmapace welcomes qualified and motivated candidates to apply for the Director of Statistics position. Pharmapace is a fast growing and specialized consulting/outsourcing company serving the biotech and pharmaceutical companies in their clinical development programs. We offer a stimulating working environment and excellent career growth opportunity.

Compensation Range: $160K - $230K

The primary responsibilities of this position are to provide statistical consulting to biotech and pharmaceutical clients throughout drug development, with a focus on clinical data analysis strategy, study design, regulatory submissions and communications, mentoring statisticians, and supporting business proposals. The role also includes supervising statistical staff and providing training and cross-functional leadership.

Key Responsibilities

• Provide statistical consulting to clinical study design and protocol development
• Develop analysis plans and strategies to support regulatory submissions
• Prepare statistical reports and interpret analysis results for regulatory submissions, if needed
• Review clinical study reports and other regulatory submission documents
• Lead statistical methodology research and stay current on statistical methodology and drug development
• Identify and provide solutions to statistical issues
• Mentor other statisticians in their support of client projects to ensure timely and high-quality delivery of analysis package

QUALIFICATIONS

Education:

Doctoral degree in Statistics, Biostatistics, or Mathematics

Experience

• 10+ years of relevant experience in pharmaceutical, biotech, or clinical research organization (CRO) industry, including minimum of 6+ years of supervision experience.
• Direct participation in design, planning, conduct, analyses, and reporting of clinical trials.
• Direct participation in regulatory submission activities.

Skills

• Deep understanding of statistical concepts and methodologies related to clinical trials and drug development
• Working knowledge of SAS and/or R
• Comprehensive knowledge of regulatory guidelines
• Excellent organizational and project management skills
• Highly motivated with excellent interpersonal and communication skills

Pharmapace offers competitive salaries plus stock options, 401K plan with company match, health/dental/vision insurances, and holiday/vacation benefits.Pharmapace is an equal opportunity employer. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin/ancestry, age, disability, marital status, and veteran status.