Director, Biostatistics - Job ID: DBPA

Ascendis Pharma; Palo Alto (CA); On-site; USD 225,000 - 240,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Biostatistics Lead to drive statistical activities for drug development. In this pivotal role, you will lead study biostatistics, ensuring alignment with strategic priorities while collaborating with cross-functional teams. Your expertise in statistical analysis and clinical study design will be crucial in delivering best-in-class therapies for unmet medical needs. This dynamic environment offers opportunities for professional growth and skill development, making it an exciting place for passionate professionals to thrive and make a significant impact.

Benefits

401(k) plan with company match

Medical, dental, and vision insurance

Life and AD&D insurance

Short and long-term disability benefits

Pet and Legal Insurance options

Employee Assistance Program and Discounts

Professional Development opportunities

Health Savings Account (HSA)

Flexible Spending Accounts

Paid parental leave

Qualifications

• 10+ years of experience in biostatistics within the pharmaceutical industry.
• Expertise in statistical analysis and clinical study design.

Responsibilities

• Lead statistical activities for drug development and ensure alignment with company priorities.
• Collaborate with teams to facilitate product development and registration processes.

Skills

Statistical Analysis

SAS Programming

Communication Skills

GCP and ICH Guidelines Knowledge

Clinical Study Design

Education

PhD in Statistics

Tools

SAS

Job description

Ascendis Pharma - Biostatistics Lead Position

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology, Rare Disease, and Oncology.

At Ascendis, we pride ourselves on exceptional science, visionary leadership, and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we utilize our TransCon drug development platform to develop new, potentially best-in-class therapies for unmet medical needs.

Our culture fosters a workplace where skilled, adaptable, and resourceful professionals can make a significant impact. We offer a dynamic environment for growth and skill development.

The successful candidate will provide leadership and execute biostatistics activities related to drug development, ensuring alignment with Ascendis Pharma's priorities. This role reports to the VP of Biostatistics and is based in Palo Alto.

Key Responsibilities

• Serve as a Lead Study Biostatistician, including sample size calculation, statistical analysis plan authorship, and exploratory analysis.
• Provide statistical consultation on study design, protocol writing, analysis planning and execution, clinical study reports, tables, figures, listings, and regulatory submissions.
• Lead and review study data during clinical trials to ensure adherence to plans and proper statistical assumptions.
• Collaborate with cross-functional teams to facilitate product development and registration processes, meeting deliverables and timelines.
• Manage biostatistics vendors, identify risks, and resolve issues with CROs.
• Support non-routine projects in drug development activities as needed.

Salary Range: $225,000 - $240,000 per year.

Knowledge, Skills, and Experience

• PhD in statistics or equivalent, with at least 10 years of relevant industry experience.
• Excellent communication skills, both written and verbal.
• Extensive knowledge of GCP, ICH guidelines, and FDA regulations.
• Strong programming skills in SAS.
• Ability to analyze issues from multiple perspectives and apply appropriate concepts.
• Demonstrated experience in providing statistical input into clinical study design, data analysis, interpretation, and messaging.

Additional Benefits

• 401(k) plan with company match
• Medical, dental, and vision insurance
• Life and AD&D insurance
• Short and long-term disability benefits
• Pet and Legal Insurance options
• Employee Assistance Program and Discounts
• Professional Development opportunities
• Health Savings Account (HSA) and Flexible Spending Accounts
• Incentive compensation plans
• Additional insurance options and mental health resources
• Paid parental leave

Note to Recruiters: We do not accept unsolicited candidate presentations. Candidates introduced without prior written permission from our HR team will not be acknowledged.