Senior Biostatistician managing statistical expertise for Arthrex's Research team in Munich. Overseeing study designs, compliance, and analytics to support medical device research.
About the role
- Director managing early-stage oncology clinical studies at Pfizer. Leading clinical protocols and collaborating with global teams to ensure timelines and quality.
Responsibilities
- Lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology.
- Work in close collaboration with the Global Development Lead (GDL) and members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s).
- Lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines.
- Work with other functional disciplines to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as needed within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).
- Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s).
- Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results.
- Support execution for all FIH programs through proof-of concept.
- Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
- Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics.
- Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors.
- Support and assist in the development of publications, abstracts, and presentations.
- May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.
- Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of early signs of efficacy [ESoE] and POC trials).
- Lead the preparation of clinical protocols and support other critical documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents.
- Foster a transparent environment that builds strong partnerships and mutual trust among teams and therapeutic areas.
- Coordinate with other clinical research activities within Oncology Research Development (ORD) and the broader Worldwide Research and Development (WRD) organization.
- Develop effective collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine, and development operations.
- Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated into relevant programs for early efficacy signs and POC, as well as patient stratification.
- Establish and support relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and guidelines into development plans and study designs, as well as manage study recruitment, analysis, interpretation, and presentation of results.
- Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas, including key clinical development issues.
- Perform other duties as assigned related to clinical programs.
- Support functional area priorities and contribute to or lead departmental initiatives as requested.
Requirements
- Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR MS and a minimum of 7 years of experience in a similar role in industry/CRO, OR BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
- Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
- Experience in or strong understanding of Oncology Drug Development especially in Early Development
- Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
- Strong scientific writing skills and communication skills (written and verbal)
- Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis.
- Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations.
- Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance.
- Experience building consensus and driving change across all levels of the organization including senior management.
- Data listing review experience
- Critical thinker, with experience working collaboratively in a fast-paced, team-based matrix environment as well as working independently when appropriate
- Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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