Dear Allstat,
Associate Biostatistics Director
Permanent
Based in Belgium (100% on site)
Excellent salary
A rapidly growing global biopharmaceutical company has a permanent opportunity for an Associate Biostatistics Director. This is to be based Belgium.
KEY RESPONSIBILITIES:
- Contributes to product development strategy and serves as a project representative in registration and communication activities. Represents and provides input to his/her supervisor for statistical issues in communications with regulatory authorities. Authors Statistical Analysis Plan text. Reviews regulatory documents such as CSRs, as well as summary documents. Provides expert statistical consulting to development teams.
- Provides leadership in biometrics activities pertaining to study projects. Provides input into development of the CDP and individual study design. .
- Provides specification and reviews draft randomization schedules. Primary SAP author. Determines and provides appropriate sample size calculations for specific objectives of study design.
- Reviews statistical outputs. Primary author of the statistical methodology sections(s) of study reports for study and integrated summary reports.
- Consults with the Medical Writer and Physician on the interpretation of efficacy results. Reviews CRFs. Reviews abstracts, posters, and manuscripts to support Medical Affairs.
- Identifies the need for contractors and supervises contractors to support projects. Participates in providing statistical training to Global Biometrics and other Research and Development staff.
Education & Experience Requirements
- Masters or PhD degree in Biostatistics or a closely related field.
- 8 years pharmaceutical industry or other relevant experience
- 3+ years of programming in SAS
- Ability to confidently communicate with and effectively present information to customers, senior management and other departments.
- Strong SAS programming skills using SAS/base, SAS/stat, SAS/graph, and SAS macro.
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Ability to work independently and oversee deadlines with a high degree of flexibility and commitment.
- Take ownership of projects and moves them forward without supervision
- Ability to take full accountability and ownership of deliverables.
- Actively seeking ways to improve processes and work flow
- Must speak Dutch
For a confidential consultation call Laura Christie on +44 207 633 4825 or email your CV to [log in to unmask]<mailto:[log in to unmask]>
I look forward to hearing from you.
Kind regards,
Laura
Laura Christie
Principal Consultant, Biometrics, Europe
Recruiting experts in Pharma
HAYS Recruiting experts worldwide
25-27 Wootton Street
London
SE1 8TG
T: +44 207 633 4825
M: +44 7900 932031
F: +44 207 922 7101
E: [log in to unmask]<mailto:[log in to unmask]>
hayspharma.com
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