Director of Biostatistics
Ipsen Bioscience, Inc.
Director of Biostatistics
Summary / purpose of the position
The Director of Biostatistics will be working in a cross‑functional team, responsible for providing project-level statistical expertise and leadership in the development of Ipsen Rare Disease assets.
This position reports to the Vice President of Biostatistics and Programming, based in the USA.
Main responsibilities / job expectations
- Work as project-level lead biostatistician in cross-functional team(s). Responsible for providing strategic support to Ipsen asset team(s), as well as authoring and reviewing key study documents such as study protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents.
- Serve as a key contributor in project planning. Work collaboratively with internal and CRO team members to coordinate the planning and execution of biostatistics deliverables with quality and within timeline.
- Provide oversight and guidance to ensure CRO partner understands the nature of the clinical data being collected and the approaches to summarizing the information. Validate and QC CRO’s work to ensure the quality and accuracy of the statistical deliverables.
- Help prepare and validate analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis.
Knowledge, abilities & experience
- PhD in statistics or biostatistics with at least 7 years of experience in pharmaceutical industry or MS with at least 10 years of pharmaceutical industry experience.
- Advanced knowledge and practical experience of widely used clinical study design as well as complex study designs. Hands-on familiarity with common and advanced statistical methodology including methods adopted in adaptive design. Expertise in applying, analyzing, reporting and the interpretation of both descriptive and inferential statistics.
- Proficiency with statistical software tools such as SAS, R, EAST, nQuery, JMP, etc. Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
- Excellent oral and written communications skills.
- Strong collaborative skills and ability to work with a global cross-functional team.
- Strong project and time management skills.
- Rare disease drug development experience is highly desired.
- Regulatory submission (US FDA, EMA, PMDA) experience is highly desired.
Key Technical Competencies Required
- Strong attention to detail, excellent and direct communication skills, strong interpersonal skills, and cross-cultural understanding and sensitivity
- Ability to see the big picture, while keeping an eye on the detail.
- Ability to take initiative with a positive attitude in all circumstances.
- Flexible; independent problem solving and self-direction.
- Eager and interested in learning and growing
- Thorough knowledge of statistics and the drug development process
- Understanding of SAS programming concepts and techniques in the pharmaceutical industry and ability to correct limitations in strategy proactively
- Ability to manage multiple complex projects and assess resource needs
Communication & Interpersonal Skills
- Language: English is required
- Written: excellent
- Verbal: excellent
- Interpersonal: excellent
- Excellent verbal and written communication within the group and across other functional areas
One Ipsen Way of Being
(The below apply for all employees and described how to act with a biotech way of being)
We Trust Each Other
- Respect each other and all our stakeholders
- Empower others
- Respect & be open to inclusion and diversity
- Enable feedback and foster a speak-up culture
- Embrace cross-team collaboration
- Be transparent and share information
We share and learn every day
- Be proactive in learning from each other and through experiences
- Listen and be open to views and needs of all external stakeholders
- Seek transformation through innovation
We own our outcome
- Be accountable and responsible
- Set clear expectations and prioritize
- Be results and value driven, not task-oriented
- Bring solutions
- Seek continuous improvement to be better always
- Own our Company Social Responsibility strategy
We honor our word
- Walk the talk & talk the walk
- Ensure that we make ethical decisions, stay compliant at all times
- Never compromise on quality
- Care for our employees, patients and society and the environment
We drive to win together
- Be entrepreneurial
- Fast in turning our ideas into action; be agile
- Be demanding of ourselves as we strive for success
- Believe in making a difference
- Celebrate success
- Enable talent inclusion and diversity
In order to maintain a safe work environment, Ipsen requires all employees to be fully vaccinated (with booster if eligible) against the Covid 19 virus at the time of employment.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.