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Our mission at Akkodis is clear: create a smarter future together We are a one-stop-shop for engineering, IT, Life Science, and new technologies. Our combined passion for talent and technology allows us to look at the world differently.
With our 360° offer, we support companies in all sectors in implementing Smart Industry solutions, from upskilling entire teams to delivering complete projects.
Our added value? Make the incredible happen
At Akkodis, you can steer your career in the direction you desire: choose a consulting role, join solutions teams, or be at the forefront of new innovations within our research centres—the choice is yours
Job Description:
As a biostatistician, you will provide expert statistical input, contribute to development plans, design, protocol writing, statistical analysis, and interpretation of clinical study results. You will ensure the timely delivery of high-quality analysis results to support decision-making and provide statistical oversight and guidance to teams and outsourcing partners.
Responsibilities:
1. Provide statistical input for the design, analysis, and interpretation of clinical studies and development plans, collaborating closely with stakeholders such as clinical representatives, safety teams, and data management teams.
2. Write and review key clinical and statistical documents, including Protocols, Statistical Analysis Plans (SAP), Data Management Plans (DMP), Case Report Forms (CRF), and Clinical Study Reports (CSR).
3. Deliver high-quality, timely statistical analysis results to support accurate and prompt decision-making.
4. Serve as a statistical representative within cross-functional study teams, offering statistical support and solutions.
5. Support the preparation of briefing books, regulatory submissions, health authority requests, publications, and other relevant documents.
6. Engage with health authorities as needed.
7. Contribute to internal process improvements and the development of new statistical capabilities.
8. Maintain current scientific and regulatory knowledge.
Required Competencies:
* MSc or PhD in Statistics or a related field.
* Experience as a statistician in the pharmaceutical industry.
* Proficiency in English (oral and written).
* Strong programming skills in SAS (Macro, SQL) and R (functions, packages).
* Solid knowledge of statistical methodologies applied to non-clinical, pre-clinical, and clinical projects.
* Ability to propose and implement new statistical methodologies.
* Excellent understanding of GCP and ICH guidelines.
* Strong communication skills, capable of explaining complex statistical concepts to non-statisticians and building good stakeholder relationships.
* Leadership skills to lead statistical and programming teams.
* Ability to manage, drive, and meet project timelines.
* Team-oriented, able to work effectively in multidisciplinary teams.
* Extensive knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10).
* Technical expertise in CDISC standards (ADaM, SDTM).
* Significant experience in submissions and interactions with health authorities.
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