Director, Biostatistics - Job ID: DBPA

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

401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resources
Paid leave benefits for new parents

Life at Ascendis Pharma

Thrive Here & What We ValueCollaborative work environment | Opportunities for professional growth and development | Flexible work schedule options | Recognition for outstanding performance</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient's lives | Guided by core values of Patients, Science, and Passion | Use TransCon® drug development platform to fulfill mission of developing new therapies | Advancing programs in Endocrinology Rare Disease and Oncology | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets | Seeking passionate People Leader to join growing function | Part of People Leader community with three People Leaders based in Hellerup and Princeton, US | Responsible for well-being and personal development of team members in Denmark | Work closely with Lene Rhein Larsen, People Leader, to continuously improve governance and people processes | Report to Lars Tranberg Pettersson, CIO and work out of our Hellerup office.</s> | Dynamic Workplace for Employees to Grow and Develop Their Skills | TransCon® Drug Development Platform to Fulfill Mission of Developing New and Potentially Best-in-class Therapies to Address Unmet Medical Needs | Exceptional Science, Visionary Leadership, and Skilled and Passionate Colleagues | Collaborative Environment for Skilled, Adaptable, and Highly Resourceful Professionals to Make Their Mark</s> | 1. Entrepreneurial and international company | 2. Short line of command | 3. GCP & GVP regulated environment | 4. Exciting product pipeline | 5. Highly skilled and experienced colleagues</s> | Collaborative culture on an accountability-based team | Unique offerings of Pet Insurance and Legal Insurance | Employee Assistance Program | Employee Discounts | Professional Development | Health Saving Account (HSA) | Flexible Spending Accounts | Various incentive compensation plans | Accident, Critical Illness, and Hospital Indemnity Insurance | Mental Health resources | Paid leave benefits for new parents</s> | 1. Guided by our core values of Patients, Science, and Passion | 2. Use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate bestin-class potential to address unmet medical needs. | 3. Advancing programs in Endocrinology Rare Disease and Oncology. | 4. Collaborating with partners around the world on the development of TransConbased products for other therapeutic areas and markets.</s> | 1. PatientCentric Approach | 2. ScienceDriven Innovation | 3. Passionate Team Members | 4. Collaborative Environment | 5. Dynamic Role</s> | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets</s> | Fast-paced environment with cross-functional, global teams | Collaborative, international and informal environment where we challenge and learn from each other</s> | Patient-centric, science-based, performance-driven | Creating an outstanding workplace</s> | Patient-centric approach to drug development | Emphasis on innovation and scientific excellence | Collaborative work environment with opportunities for professional growth | Focus on making a meaningful difference for patients through our innovative TransCon technology platform | Strong commitment to employee well-being and work-life balance</s> | Visionary leadership</s> | Fostering a place where skilled, adaptable, and highly resourceful professionals can truly make their mark | Using TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs | Advancing programs in Endocrinology Rare Disease and Oncology</s> | Dynamic, fast-growing global biopharmaceutical company | Onsite presence in our Palo Alto, CA office 3 times per week or more, as necessary | Travel within the US &/or to our corporate headquarters in Denmark may be necessary | Focuses on exceptional science, visionary leadership, and skilled and passionate colleagues. | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs. | Fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. | Offers dynamic workplace for employees to grow and develop their skills.</s> | Culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark.</s> | Dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States | Providing strategic leadership to ensure the successful design and execution of non-clinical and clinical trials as well as Life Cycle Management Strategies | Engaging closely with internal peers and externally stakeholders such as the FDA, EMA, and other key regulatory bodies | Formulating strategies, enhancing performance, implementing relevant policies, and providing key insights that enable the organization to operate collaboratively and proactively.</s> | Fast-growing biopharmaceutical company with locations in Denmark, United States, Germany, United Kingdom, Italy, Spain, and France | Applying innovative TransCon technology platform to build a leading, fully integrated biopharmaceutical company | Diverse pipeline designed to make a meaningful difference for patients | Started launching Endocrinology Rare Disease portfolio globally, in the US, Germany & Austria, with plans for rapid expansion</s> | Passionate about patients and science | Collaborative mindset | Diverse workforce offers a more personal understanding of our customers' needs and concerns | Trusting and appreciative company culture | Value colleagues of diverse backgrounds and their abilities to contribute unique viewpoints and perspectives to all aspects of the business, from drug development to marketing.</s> | Unique Ascendis DNA: flat hierarchies, short lines of communication, and a dynamic, open, and informal working atmosphere | Tremendous opportunity to make an impact | Great team and corporate events | Attractive base salary, sponsored pension scheme (bAV), paid internet, exciting short- and long-term incentives | Structured onboarding program | Tailor-made training and development opportunities embedded in a well-resourced training budget | Direct connection to tram station, parking lots for cars and bikes | Soft drinks and wide variety of snacks | State-of-the-art workplace with iPhone, iPad, and brand-new laptop.</s> | Unique Ascendis DNA: flat hierarchies, short lines of communication, dynamic working atmosphere, tremendous opportunity to make an impact, great team and corporate events | Structured onboarding program, tailor-made training and development opportunities embedded in a well-resourced training budget | State-of-the-art workplace with iPhone, iPad, and brand-new laptop</s> | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.</s> | Passionate about training and development — and ready to build something from the ground up | Patients, Science, and Passion core values | Adaptable and highly resourceful professionals can truly make their mark</s> | Fast-paced, cross-functional environment where your coordination skills drive real impact | Innovative treatments for rare diseases while growing commercial experience | Commitment to making a meaningful difference in patient’s lives | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.</s> | Collaboration with cross-functional, global teams working together to achieve extraordinary results | Informal, open environment where innovation and change are key</s> | Collaborating with cross-functional, global teams working together to achieve extraordinary results | Entrepreneurial, informal, and open environment where innovation and change are key | Passionate about helping Commercial organizations gaining full value of their applications | Committed to making a meaningful difference in patients’ lives</s> | Collaborates with cross-functional scientific affairs team members to ensure that scientific standards are aligned across the organization | Stays current with industry trends, disease state areas, and treatment guidelines that impact training content | Offers employee discounts and mental health resources | Provides paid leave benefits for new parents</s> | Commitment to making a meaningful difference in patient's lives | Key strategic endeavour by Ascendis to expand global footprint in partnership with indirect affiliates across the globe</s> | Collaborating with cross-functional partners to identify and respond to local opportunities and customer needs</s> | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs | Commitment to advancing our Medical Affair’s teams’ scientific knowledge and skills, while making a significant impact in the lives of our patients</s> | Dynamic environment | Opportunity to develop skills and knowledge within the team | Flexible working hours to accommodate study and work</s> | Use TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | Diverse pipeline designed to make a meaningful difference for patients</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patients' lives | Exceptional science, visionary leadership, and skilled and passionate colleagues</s> | Fast-growing biopharmaceutical company with locations in Denmark, United States, Germany, United Kingdom, Italy, Spain, and France</s> | TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies</s> | Collaborative environment with strong relationships between internal team and external partners | Inclusive environment for all employees</s>