Job Description
Our client, a cutting edge scientifically driven Biotech company with commercial product and strong development pipeline, now seeks a Biostatistics Senior Manager for their Biostatistics function operating within Clinical Development, in their Dublin office. Flexible hybrid work environment.
The Biostatistics Senior Manager will provide statistical leadership and technical expertise in support of clinical development and some post-marketing activities for a therapy area supporting new office / start-up environment.
In collaboration with the head of Biometrics and other project statisticians, this hire will build partnership with stakeholders within Clinical Development; participate in and support the design, planning and execution of Clinical Development activities such as protocol, statistical analysis plan, reporting and interpretation of clinical study results, and regulatory interactions.
The ideal candidate will have advanced qualifications in Biostatistics / Statistics and operating in similar role within Pharma / Biopharma industry or with a CRO; therefore having proven knowledge of regulatory requirements ensuring the company meets regulatory, scientific, and business objectives.
Key Responsibilities:
- Biostatisticians work collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of company clinical data in efficiently achieving regulatory, scientific and business objectives.
- Collaborate with outside experts and internal colleagues to present and publish trial results and statistical analysis within and outside of the company.
- Has knowledge of regulatory requirements to ensure the company meets regulatory, scientific, and business objectives.
- Oversees training programs for the job family and provides strategic direction for the group.
- Works collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
- Provides leadership for a departmental strategic initiative.
- Able to set up and influence collaborations with external academic or government organizations to extend visibility or business need of the company.
- Can set up data monitoring committees for clinical studies.
- Can use competitive intelligence to influence clinical development strategies.
Person Spec:
- BS degree in Life Science with advanced qualifications in Biostatistics or equivalent. MSc or PhD in statistics or biostatistics is preferred.
- 7+ years of Statistical / Biostatistical clinical development experience, the majority of which in pharmaceutical / biotech industry or with a CRO.
- Experience with regulatory interactions (FDA and/or EMA), assisting with preparation of filing documentation, etc. Solid understanding of clinical trial principles and regulatory requirements.
- Knowledge of industry data standards.
- Proficiency with statistical analysis software such as SAS and/or R.
- Effective verbal and written communication and strong interpersonal skills.
- Demonstrated ability to work in a team environment.
- Demonstrated strong problem solving and risk-mitigation skills.
For further details please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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