Main Responsibilities
- Lead one moderate project/indication or a highly complex late-phase rare disease study; or lead multiple projects (including at least one complex project).
- With minimal direction, provide statistical support and scientific leadership; accountable for statistical aspects of early/late clinical development/medical affairs plans, studies, and submissions activities (as applicable), ensuring quality, external stakeholder relevance (e.g., regulators, medical journals), and scientific validity.
- Mentor project team members; promote teamwork, quality, operational efficiency, innovation; ensure compliance with SOPs and departmental standards.
- Plan/track project activities, timelines, and resource use; justify resource needs; optimize resource utilization; leverage external groups (e.g., CROs, DMC); handle unscheduled workload increases.
- Provide technical guidance to junior staff.
- Collaborate across functions and communicate with senior leadership; represent statistics in regulatory meetings.
- Participate (and lead if applicable) in scientific/technology working groups or cross-functional initiatives; contribute to process optimization and statistics standards.
Basic Qualifications
- PhD or Masterโs degree in Statistics/Biostatistics/Applied Mathematics/Bioinformatics/Computational Biology/Data Science or related quantitative/scientific field.
- PhD: minimum 5 years; Masterโs: minimum 7 years in pharma/biotech/biologics/medical device/diagnostics or related.
Preferred Qualifications/Skills
- Strong project/study management; advanced statistics knowledge; pharma clinical development knowledge; experience with submissions/regulatory interactions; therapeutic area experience.
- Strong interpersonal/communication skills; ability to represent the company in consortiums/professional associations.
Benefits (as stated)
- Rewards package; healthcare and wellbeing benefits; at least 14 weeksโ gender-neutral parental leave.