Title:
Principal Biostatistician F/M
Company:
Ipsen Innovation (SAS)
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
Purpose of the mission
The Principal Biostatistician is responsible for providing broad statistical support and contributing strategically to a cross-functional team, providing study-level statistical expertise and leadership in development of Ipsen’s Oncology Assets. Tasks can include study design, protocol development,
sample size / power calculations and simulations, statistical analysis methodology, statistical analysis plan preparation, blinded in-trial data quality review, pre-database lock data quality control, supporting development of table / listing / figure templates, programming and production, oversight of contract or
CRO resources, as well as preparation, integration and documentation of clinical regulatory submission package, in accordance with CDISC standards.is expected to act independently as the statistics subject matter expert for all clinical development programs and studies, while ensuring adherence to all regulatory requirements.
The Principal Biostatistician is expected to have an in-depth understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data and multiplicity handling.
- She/he will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, execution and evaluation of clinical trials.
- she/he will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively within the biometrics department and also with clinicians, clinical operations, medical writing, regulatory affairs, information technology and other colleagues, service/technology providers, as well as external drug development agencies or organizations.
- She/he will have a good understanding and the capacity to sustain the dialog in consultations or advisory board meetings with biostatistical, clinical and regulatory key opinion leaders about clinical study design, execution and evaluation from the statistical perspective.
• Ability to make appropriate, rational and well-justified decisions in ambiguous situations with incomplete
or uncertain information; Ability to prioritize tasks and direct team accordingly
Knowledge & Experience :
- Experience of oncology disease clinical development and regulatory submissions
- Comprehensive knowledge of statistical theory and methods
- Demonstrated ability to apply statistical, programming, and data management knowledge to clinical studies and
- Expertise in SAS and R programming for data management, conversion, review and visualization, statistical analysis, tabulation, listing and graphs of clinical trial data
- Excellent verbal and written communication skills; Leadership and team-ability with effective intercultural
- competences, diplomacy, negotiation and communication
- Self-management skills with the ability to take initiatives, develop and evaluate alternative scenarios and options, and present them effectively to the colleagues and leadership of the company
- Proficiency in MS Word, Excel, and PowerPoint software programs
- Excellent problem-solving and strategic-thinking skills
- Sound knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.)
- Excellent written and oral communication and presentation skills
- Ability to identify and address issues proactively in a timely manner
Education / Certifications
- Master's degree and a minimum of 6 years of relevant industry experience is required
Education / Certifications
- A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 3 years of relevant clinical biostatistics experience in pharma, biotech or medical device industry
Language:
- English
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Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.
Top Skills
What We Do
Ipsen is a French leading global mid-size biopharmaceutical company headquartered in Paris, France focusing its efforts where unmet medical needs are greatest. Ipsen develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Rare Disease and Neuroscience.
We have over 5000 employees worldwide and our medicines are registered in more than 100 countries, with direct commercial presence in over 30 countries. Ipsen has 4 global R&D hubs and 3 pharmaceutical development centers around the world
