Position holder leads the development and execution of biostatistical strategy for Medical Affairs as well as Health Economics and Outcome Research by supporting the development of evidence generation plan, pricing authorities interactions and scientific communication. Responsibilities include representing Biostatistics and Data Management department at Project Teams of Medical Affairs and Market Access including Publication Team as well as leading complex studies from design to analysis execution and interpretation.
The position holder will show statistical leadership, strategic thinking and excellent communication skills for the interactions with internal (Medical affairs and HEOR) and external stakeholders (key opinion leaders, pricing agencies, CROs programmers and statisticians); in addition it may coordinate other statisticians assigned to the same project or lead a small team of statisticians. This position works under minimal supervision to conduct his/her activities and to solve complex project problems.
1. Evidence Generation Strategy
Act as project statistician for Medical Affairs and HEOR activities. As project statistical expert contributes to evidence generation and publication plan to ensure overall biostatistical strategy can deliver according to business needs and pre-specified product profile. Helps to maximize the success of the drug product.
Act as statistical expert in the assigned projects. Ensures that statistical activities for evidence generation are scientifically sound and that the efficacy and safety information meet requirements of internal (Medical Affairs and HEOR) as well as external stakeholders (KOLs, HTA and pricing agencies). Drives the utilization of most efficient and innovative study design to maximize the success of the drug product.
Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the project. Leads planning and analysis of integrated efficacy and safety data.
2. Statistical activities
Leads statistical activities for complex studies. Act as statistical expert in the assigned projects guides team in using the most efficient or innovative study design as well as in analysis interpretation by considering Medical Affairs and HEOR global and regional requirements for the compound. Responsibilities include protocol development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR).
Leads the development and execution of statistical activities for scientific publication from the planning throughout its execution. Ensures clear and scientifically sound interpretation of publications from a statistical perspective.
3. CRO / Vendor Oversight:
Participates in drafting request for proposal for CRO selection. Reviews and negotiates baseline budget and timelines; Leads CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high quality deliverables.
4. Pricing authorities interactions / negotiations
Oversees biostatistical activities for executing analyses for national pricing authorities submissions. May author documents and responses submitted to Pricing Authorities globally with some guidance from supervisor. May represent biostatistics to Pricing Authorities meetings as needed.
5. Global BDM Strategy to Improve Evidence Generation:
Leads global BDM initiatives to improve the harmonization and efficiency of evidence generation activities with minimal supervision.
Research statistical methodologies and addresses specific statistical issues in the design and interpretation of clinical studies.
Education: PhD or Master’s degree in statistics or biostatistics
Experience:Minimum 7 years of relevant experience with PhD or minimum of 10 years with Master’s degree of relevant experience in the pharmaceutical industry
- Expert knowledge of drug development and statistical methodologies.
- Excellent programming skills in SAS and/or R.
- Excellent oral and written communication skills.
- Working knowledge of statistical software package such as NQUERY, EAST, etc.
- Excellent Project planning skills.
- Demonstrated expertise in trial design and data analysis.
- Excellent collaborating skills.