Offer summary

Qualifications:

PhD in statistics or equivalent with at least 10 years of relevant experience in the biotechnology or pharmaceutical industry., Strong knowledge of GCP, ICH guidelines, and FDA regulations., Proficiency in programming with SAS and excellent communication skills., Demonstrated experience in statistical input for clinical study design and data analysis..

Key responsibilities:

Lead study biostatistician responsible for sample size calculations and statistical analysis plans.

Provide statistical consultations on clinical study designs and regulatory submissions.

Review study data during clinical studies to ensure alignment with planned objectives.

Collaborate with cross-functional teams to optimize product development and manage biostatistics vendors.

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, 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 VP of
Biostatistics.

Key Responsibilities

Serves as a Lead study biostatistician and performs calculation of sample sizes, authors statistical analysis plans and performs exploratory analysis.
Provides statistical consultations on clinical study designs, protocol writing, analysis planning/execution, clinical study report, table/figure/listings, statistical interpretations and regulatory submissions
Provides leadership and perform study data reviews during clinical studies to ensure that clinical studies are in the right course as planned with proper checking of assumptions used for statistical analyses
Collaborates with cross functional peers to facilitate and optimize the product development and registration process to meet deliverables and timelines for statistical data analysis and reporting
Manages biostatistics vendors, identify potential risks and resolve issues with CROs
Assists non-routine projects as applicable in support of drug development activities

Salary Range: $225-240K/year

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Requirements

Knowledge, Skills and Experience

PhD in statistics or equivalent, with at least 10 years of relevant experience in biotechnology or pharmaceutical industry
Excellent interpersonal and communication skills both written and verbal
Extensive knowledge of GCP, ICH guidelines, FDA regulations
Strong knowledge and skills of programming in SAS.
Ability to examine issues from various perspectives and apply appropriate concepts to address situations
Demonstrated experience in providing statistical input and direction into the design of clinical studies, data analytic approaches, interpretation of findings and crafting of key messages

Benefits