Director, Biostatistics - Job ID: DBPA

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

Job summary

Join a dynamic biopharmaceutical company that is committed to advancing innovative therapies in Endocrinology, Rare Disease, and Oncology. This role offers the opportunity to lead biostatistics activities, ensuring alignment with the company's objectives while collaborating with cross-functional teams. With a focus on exceptional science and a culture that fosters professional growth, you'll play a pivotal role in drug development, providing statistical guidance and ensuring timely delivery of analyses. If you are passionate about making a difference in patients' lives and thrive in a fast-paced environment, this position is perfect for you.

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

Employee Assistance Program

Employee Discounts

Professional Development opportunities

Health Savings Account (HSA)

Flexible Spending Accounts

Qualifications

• 10+ years of relevant experience in biotechnology or pharmaceuticals.
• Extensive knowledge of GCP, ICH guidelines, and FDA regulations.

Responsibilities

• Lead biostatistics activities associated with drug development.
• Provide statistical consultations on clinical study designs.
• Manage biostatistics vendors and resolve issues with CROs.

Skills

Statistical Analysis

SAS Programming

Interpersonal Skills

Communication Skills

Clinical Study Design

Regulatory Knowledge

Education

PhD in Statistics or Related Field

Job description

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.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

The individual in this position will provide leadership and execution of biostatistics activities associated with drug development to ensure that development activities are consistently aligned with the priorities and objectives of Ascendis Pharma. The role reports to the VP of Biostatistics and is based in Palo Alto.

Key Responsibilities

• Serve as a Lead study biostatistician, performing calculations of sample sizes, authoring statistical analysis plans, and conducting exploratory analyses.
• Provide statistical consultations on clinical study designs, protocol writing, analysis planning and execution, clinical study reports, tables/figures/listings, statistical interpretations, and regulatory submissions.
• Lead and perform study data reviews during clinical studies to ensure they stay on course as planned, including proper checking of assumptions used for statistical analyses.
• Collaborate with cross-functional teams to facilitate and optimize product development and registration processes, ensuring timely delivery of statistical data analysis and reporting.
• Manage biostatistics vendors, identify potential risks, and resolve issues with CROs.
• Support non-routine projects as needed in drug development activities.

Salary Range: $225-240K/year

Note to Recruiters

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from a Talent Acquisition Partner or HR Director) is prohibited. Unauthorized submissions will not be acknowledged.

Knowledge, Skills, and Experience

• PhD in statistics or related field, with at least 10 years of relevant experience in biotechnology or pharmaceuticals.
• Excellent interpersonal and 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 various perspectives and apply appropriate concepts.
• Proven experience in providing statistical input and guidance in clinical study design, data analysis, interpretation, and messaging.

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
• Employee Assistance Program
• Employee Discounts
• Professional Development opportunities
• Health Savings Account (HSA)
• Flexible Spending Accounts
• Incentive compensation plans
• Additional insurances (Critical Illness, Hospital Indemnity)
• Mental Health resources
• Paid parental leave