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Statistical Science Director

Remote, USA | Planet Pharma

  • Industry:
    HR / Recruitment Services
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Biotech/R&D/Science
    Consulting - IT
  • Experience:
Job Description:
67 people have viewed this job

Role Summary:


Biometrics & Information Sciences (B&I) drives good design to generate data needed for quality decision making. B&Is goal is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.

TA Statistics is the group that oversees and delivers all the statistical and programming contribution to design, decision-making, interpretations and communication internally and externally for the TA portfolio of projects and is engaged in shaping the TA external environment.

Responsibilities:


To lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation of products.

Leadership to statistical staff on the product world-wide so that all work is carried out with regards to standards and external regulations

Through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions

Quantifying the benefit, risk, value and uncertainty of the emerging product profile.

Setting the standards (and enforcing compliance) for statistical work within the product;

Holding CRO/Partners accountable for the high quality standards of their deliverables;

Represent and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications;

Promote, investigate, develop and implement novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.

Develop relationships with international opinion leaders, consultants and collaborative groups.

Mentor/coach and support the education and training of Statistics staff in the technical arena

Job Dimensions


Expert Leadership role able to lead and direct project work

Accountable for the statistical work on the product world-wide

Requirements:


Leadership Capabilities @ Level 3

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

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

Requirements:

Job Dimensions


Expert Leadership role able to lead and direct project work

Accountable for the statistical work on the product world-wide

Requirements:


Leadership Capabilities @ Level 3

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

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


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