Sr. Biostatistician (Estonia)
Allucent, Estonia
Job Description
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
Summary:
The Sr. Biostatistician I (Sr1Bios) supports the statistical analysis and clinical data activities of the Allucent Biostatistics/Statistical Programming team. This position leads projects, writes statistical documents and statistical sections of study documents for simple to moderately complex studies, and provides senior review of statistical documents and outputs. This position may assist in the programming of datasets and outputs using SAS. The Sr1Bios will regularly interact with other members of the Allucent biostatistics project team and will interact with clients when leading a study.
The Sr1Bios is a member of the Biometrics staff.
Location: Europe; Estonia preferred
Key Responsibilities:
- Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial data
- Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for simple to moderate studies
- Familiarity with complex statistical methods and concepts
- Provide senior reviews of statistical documents, data, and outputs for simple to moderately complex studies to ensure quality and integrity
- Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
- Interpret and communicate results for complex statistical analyses and outputs
- Develop and/or review the statistical sections of a study protocol for simple to moderate studies
- Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses
- Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications
- Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports
- Support responses to regulatory questions on statistical issues relating to client regulatory submissions
- Working knowledge of SAS for production and validation of datasets and statistical outputs
- Write and review specifications for complex ADaM or analysis datasets
- Annotate or review annotations of TLF mocks to assist programming efforts
- Working knowledge of CDISC standards
- Review CRF design to ensure it conforms with the study protocol and analysis needs
- Review data management documents as requested to ensure integrity of study data
- Lead simple to moderate projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing
- Lead management of project budgets, the identification of out-of-scope work, and the change order process
- Function as supporting or lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings
- Accountable for leading biostatistics and programming activities for a program of studies of moderate to high complexity.
Requirements
- Bachelor’s degree; master's degree preferred, in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare
- Minimum 4 years of relevant work experience
- Good knowledge of GxP
- Familiarity with relevant regulations and guidelines
- GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements Working knowledge of computer systems, applications and operating systems
- Working knowledge of computer systems, applications and opera