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.
We are looking for an experienced Principal Biostatistician to join our Team in the United States OR Canada.
Summary:
The Principal Biostatistician (PrBios) 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 studies of all complexity, and provides senior review of statistical documents and outputs. This position may assist in the programming of datasets and outputs using SAS®. The PrBios will regularly interact with other members of the Allucent biostatistics project team and will interact with clients when leading a study.
This is a full-time, direct hire opportunity for an experienced Biostatistician Professional residing in the USA. Ideal candidates should have a strong CRO background with the ability to independently lead projects of moderate and high complexity as the lead biostatistician.
This position will be hybrid for those living near one of our office locations, however, for those further in distance the role can be offered remotely. Strong English Communication (written and verbal) is required.
Key Responsibilities:
- Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for a study of any complexity
- Remain familiar with complex statistical methods and concepts in clinical research with emphasis in the development & support of the analysis of clinical trials.
- Provide senior reviews of statistical documents, data, and outputs for studies of all complexity 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 or clinical study report for studies of any complexity level, ensuring accurate descriptions of statistical methods used
- 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
- Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions
- Maintain working knowledge CDISC standards and SAS® for production and validation of datasets & statistical outputs
- Write and review specifications for complex ADaM or analysis datasets
- Annotate or review annotations of TLF mocks to assist programming efforts
- 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 highly complex 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 the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings
- Lead biostatistics and programming activities for a program of studies of high complexity and/or of high value.
- Support staff learning & development within the company
- Identify, recommend, and execute departmental initiatives, tools, and process solutions to enhance efficiency and quality
- Provide mentoring to junior staff
- Understand and comply with all company policies and SOPs
- Review and evaluate biostatistics and statistical programming processes and procedures within the Quality Management System
- Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients
- Support in preparation of new proposals
- Establish positive relationships with current and future clients
- Maintain strong long-lasting relationships to win new and repeat business
- Contribute to other areas of business as required
Requirements
- Graduate degree (Master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology or healthcare
- Minimum 8 years of relevant work experience
- Good knowledge of GxP and knowledge of SAS
- Strong 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
- Demonstration of critical thinking and analytic skills
- Strong written and verbal communication skills including good command of English language
- Ability to work in a fast-paced challenging environment of a growing company
- Strong individual initiative
- Excellent attention to detail and commitment to quality
- Proficiency with various computer applications such as Word, Excel, and PowerPoint
- Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors
- Collaborative abilities and client focused
- Ability to effectively manage multiple tasks and projects
- Strong leadership skills
- Effective at problem solving, strategic thinking and conflict resolution
Benefits
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Leadership and mentoring opportunities
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
How to Apply: https://apply.workable.com/allucent/j/9AD372ACBF/