Senior Statistician: Late Respiratory - Barcelona, España - Morgan Philips Executive Search

Morgan Philips Executive Search

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Main

Responsibilities:

As a S enior Statistician, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.

Focus & Challenge of Position

Provide statistical leadership in support of the Global Product Statistician (GPS), be a newly appointed GPS, or lead strategic capability or business area improvements with mínimal supervision.

Serve as primary author for statistical sections of protocol concept sheets (PCS), protocols, clinical development plans (CDP), and integrated product development plans (iPDP).

Perform statistical analyses and create statistical text for clinical publications and other communications.

Provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work, holding partners/providers accountable for the quality of their deliverables.

Define and lead analysis of relevant internal and external information to inform design decisions.

Provide statistical support and leadership to clinical trial teams (CTT), clinical sub-teams (CST) and product development teams (PDT) on the development of Target Product Profile and Target Product Claims (TPP/TPC), Benefit, Risk, Value and Uncertainty (BRV(U)), clinical development plans (CDP), and regulatory strategy.

Lead development of components of regulatory submissions (eg, briefing documents, response to FDA requests, BLA/NDA, and sBLA/sNDA) and may represent company Statistics to Health Authorities (eg, Pre-IND and End of Phase II meetings).

May provide highly experienced expert statistical leadership to the development of the capability area and to PDTs, promoting good statistical practice.

To represent the company's position in their contacts with external experts.

May also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities.

Requires juggling multiple projects with varying priorities.

Requires ability to recognize issues that may critically affect statistical analyses and to relay that information to appropriate level of management.

Minimal supervision, appropriately and pro-actively consulting with key partners (eg, GPS) and line management where needed to ensure a successful outcome to agreed time, cost and quality.

Knowledge, Skills & Experience Required

MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area.

In depth knowledge of the technical and regulatory requirements related to the role.

Expert leadership capabilities to be able to lead and direct project work.

Extensive experience of Development, programme design and data analysis and interpretation.

Experience of major regulatory interactions and/or submissions.

Excellent communication skills and ability to build strong relationships.

Excellent collaboration skills required - the energy to work across global & functional boundaries, both internally and externally.