Offer summary

Qualifications:

Master's degree in Biostatistics or Statistics with at least 6 years of relevant industry experience, or a Ph.D. with 3 years of experience., Comprehensive knowledge of statistical theory and methods, particularly in oncology clinical development., Expertise in SAS and R programming for data management and statistical analysis., Excellent verbal and written communication skills, with strong leadership and problem-solving abilities..

Key responsabilities:

Provide statistical support and leadership in the development of oncology assets.

Conduct study design, protocol development, and statistical analysis plan preparation.

Oversee data quality control and ensure adherence to regulatory requirements.

Collaborate with cross-functional teams and external agencies on clinical study design and execution.

Job description

Title:

Principal Biostatistician F/M

Company:

Ipsen Innovation (SAS)

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.

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