Senior Statistician

Pharmapace, Inc.; San Diego (CA); On-site; USD 100,000 - 165,000; 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. is seeking a qualified Senior Statistician to provide leadership in data analyses for clinical studies, including regulatory submissions. The role demands a Master's or Doctoral degree in Statistics, Biostatistics, or Epidemiology, with relevant experience in clinical trials.

The ideal candidate will possess deep statistical knowledge, regulatory guidelines awareness, and SAS proficiency. Compensation ranges from $100K to $165K, inclusive of stock options and other competitive benefits.

Qualifications

• Master’s degree with 4+ years or Doctoral degree with 2+ years of relevant experience.
• Direct experience in the design, planning, conduct, analyses, and reporting of clinical trials.

Responsibilities

• Provide statistical consulting for clinical study design.
• Conduct sample size and power calculations.
• Assist in regulatory submission strategy planning.
• Write statistical reports and provide statistical interpretation for study report preparation.

Skills

Statistical methodology related to clinical trials

Regulatory guidelines knowledge

SAS

Organizational skills

Project management skills

Interpersonal skills

Communication skills

Education

Master’s or Doctoral degree in Statistics, Biostatistics or Epidemiology

Tools

SAS

Job description

Pharmapace welcomes qualified and motivated candidates to apply for the Senior Statistician 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.

The primary responsibilities of this position are to provide leadership in planning and conducting data analyses in clinical studies, and participate in planning and data analyses for regulatory submission.

Key Responsibilities

• Provide statistical consulting for clinical study design
• Review study protocols and write statistical sections
• Conduct sample size and power calculations
• Propose randomization methods and designs, and generate randomization schedules
• Assist in regulatory submission strategy planning
• Participate in study team operations and timeline discussion
• Identify issues, and provide solutions to clinical operation and data management for issues that potentially impact data analyses
• Develop and review statistical analysis plans, both for individual studies and integrated analyses for regulatory submissions
• Review programming specifications and provide input to derivation rules for data integration
• Provide input to statistical programmers to prepare CDISC compliant SDTM and ADaM datasets
• Conduct inferential statistical analyses and check model adequacy of statistical analyses
• Perform statistical validation/quality control on analyses generated by statistical programmers
• Write statistical reports and provide statistical interpretation for study report preparation
• Prepare statistical sections of clinical study reports
• Work with medical writers to assist with clinical study reports preparation
• Work with project managers to ensure timely and high quality delivery of analysis packages
• Identify and resolve statistical issues. Research and stay current with innovative statistical methodologies

QUALIFICATIONS

Education: Master’s or Doctoral degree in Statistics, Biostatistics or Epidemiology

Experience

• Master’s degree with 4+ years or Doctoral degree with 2+ years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry
• Direct participation in design, planning, conduct, analyses, and reporting of clinical trials

Skills

• Deep understanding on statistical methodology related to clinical trials and drug development
• Knowledge on regulatory guidelines
• Working knowledge of SAS
• Excellent organizational and project management skills
• Highly motivated. Excellent interpersonal and communication skills

Compensation Range: $100K - $165K

Pharmapace offers competitive salaries plus stock options, 401K plan with company match, health/dental/vision insurances, and holiday/vacation benefits.