• Master’s degree in Statistics or related field +8 years’ experience or PhD in Statistics or related field +6 years ‘experience.
• Proficient in SAS programming, able to conduct analyses without programming support, and familiar with at least some other significant statistical software (e.g., S-Plus, PASS).
• Basic knowledge of regulatory guidance documents such as ICH guidance’s.
• Demonstrated written and oral communication skills.
• Ability to work independently.
Statistician working and training on post-hoc analyses, publications, trial design and reporting activities with minimal review. Statistics representative for cross-functional teams and for review within Biostatistics & Programming, Clinical Development Operations, and Therapeutic Areas.
1. Leads statistical input for at least one disease indication, including review within Biostatistics & Programming, Clinical Development Operations, and Therapeutic Areas.
2. Leads clinical study design.
3. Leads analysis planning for clinical studies, post-hoc analyses and publications.
4. Leads statistical input to clinical study reports.
5. Provides statistical support to other disciplines associated with clinical statistics.
6. Serves as a primary contact with outside investigators in the preparation of scientific presentations and manuscripts.
7. Takes a leadership role in process improvement, training, standards development or an area of technical expertise.
PRINCIPAL RELATIONSHIPS: Biostatistics staff; Clinical Teams and associated working groups
Contacts Inside the Company: Therapeutic area scientific staff; SAS Programming; Clinical Database Management; Clinical Trials Management; Regulatory Affairs; Clinical Communications; Marketing; Clinical Pharmacology; Medical Writing, Quality Management
Contacts Outside the Company: Key opinion leaders; CRO staff; Regulatory Agencies; External trial committees; Advisory boards
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