Sr. Director of Statistical Programming - Job ID: 1105

Are you an ambitious team-player with passion for statistical programming and want to

play a key role in the success of our diverse portfolio wihin endocrinology, oncology and

ophthalmology? Then this may be a great opportunity for you.

The role

As our new Sr Director Statistical programming, you will be a key player in advancing Ascendis product pipeline, by providing strong leadership and creating and implementing the strategic direction for the Statistical programming unit. You will join a highly specialized global biometrics team of more than 30 passionate and engaged colleagues and report directly to the VP Biometrics.

Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global biometrics team, located in both Copenhagen, Denmark and in Palo Alto, California, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.

This position will report to the Head of Biometrics

You will be responsible for

• Overseeing all statistical programming activities and personnel.
• Developing and overseeing the implementation of Statistical Programming SOPs and work instructions.
• Partnering with multiple functions and diverse stakeholders and provide programming support.
• Interacting with members of cross-project teams, and biometrics personnel to establish project timelines and perform statistical analyses.
• Providing leadership to SAS programming personnel in production of summary tables, data listings and graphs required for trial report and clinical development, as well as CDISC data sets for regulatory submission.
• Managing programming activities to ensure timely delivery of tables and data listings. Provide guidance and QC/QA standards to ensure quality of deliverables.
• Overseeing budget for the Statistical Programming department.
• Manages study statistical programmer(s) and/or consultant(s)

Requirements

Your professional qualifications

You hold a relevant academic degree: A master's or a PhD degree in statistics, mathematics, computer sciences or equivalent with at least 15 years of experience within the pharmaceutical or bio-pharmaceutical industry and at least 5 years of management experience. Global experience is preferred. You are proficient in English at a professional level, both written and spoken.

• Extensive experience managing FTEs, contractors and CROs
• Prior experience in participation of NDA/BLA submissions.
• Demonstrated leadership and excellent interpersonal skills.
• Ability to work proactively while handling multiple deliverables and short timelines
• Ability to influence and communicate across functions
• Extensive knowledge of GCP, ICH guidelines, FDA regulations
• Strong knowledge and skills of programming in SAS and solid understanding of CDISC SDTM and ADAM models and standards
• Demonstrated experience in novel ways to handle data from clinical trials, e.g. develop new endpoints and statistical analysis

Personal skills

As a person, you are a curious team player besides being a strong communicator that thrives in a complex, fast-paced expanding organization.

Additionally, we expect that you are

• Proactive, accountable, and goal-oriented
• Innovative
• Good at sharing knowledge in an informal way
• Good at communicating to both internal and external stakeholders (e.g. health authorities)
• New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law

Travel: ca 20 days per year.

Office location: Palo Alto, California, USA

Salary range: $270-$290K/year