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Senior Biostatistics Manager
2 months ago
The Opportunity:
This position presents a unique chance to play a pivotal role within the clinical development team of a rapidly expanding organization.
The Senior Biostatistics Manager will engage in the planning, execution, analysis, and reporting of clinical trials, particularly focusing on the organization's vaccine initiatives for infectious diseases.
This role is based in a dynamic and innovative environment.
Your Responsibilities:
Act as the lead biostatistician within clinical development teams, ensuring all biostatistical deliverables for clinical studies are completed with precision and timeliness.
Bring forward innovative statistical methodologies and operational excellence to enhance the effectiveness of clinical development programs.
Develop comprehensive statistical sections for study protocols, statistical analysis plans, and key specifications for programming implementations.
Plan, oversee, and monitor biostatistical activities, timelines, and resources to guarantee operational excellence.
Contribute to the development of Standard Operating Procedures (SOPs) and Work Instructions related to biostatistical practices.
Collaborate with and manage both internal and external stakeholders (e.g., Contract Research Organizations, software providers, clinical development partners) to ensure project timelines and objectives are met.
Your Qualifications:
A Master's or PhD degree (or equivalent) with a minimum of 5 years (PhD) or 7 years (Master's) of relevant experience in Biotechnology, Pharmaceuticals, Regulatory Agencies, or Clinical Research Organizations.
Strong statistical acumen with the capability to apply this knowledge to address scientific and clinical challenges.
Familiarity with pertinent FDA, EU, and ICH guidelines and regulations.
Experience in prophylactic vaccine clinical trials and regulatory interactions is preferred.
Proven experience in managing relationships with CROs and vendors.
Exceptional communication skills, both verbal and written.
Ability to juggle multiple projects in a fast-paced setting.
Proficient in collaborating effectively within a dynamic, cross-functional matrix.
About the Company:
Since its inception, the organization has aimed to establish a leading mRNA technology platform, creating an infrastructure to revolutionize medicine development and delivery, supported by a world-class team. The company is committed to fostering a culture of belonging and caring for patients, employees, the environment, and communities.
Recognized as a top employer in the biopharmaceutical sector, the organization values in-person collaboration to enhance innovation and mentorship.
Join us in making a significant impact in the field of medicine.
The organization is an equal opportunity employer, dedicated to diversity and inclusion in the workplace.
