Principal Biostatistician

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 Principal Biostatistician (PrBios) supports the statistical analysis of clinical data activities of Allucent Biostatistics. This position carries out the statistical analysis as specified in the protocol and/or statistical analysis plans, may assist in the programming of datasets and outputs using SAS, and will interact with other members of the Allucent project team. The PrBios is a member of the Biostatistics staff.

Responsibilities:

• Provide protocol review and input such as sample size calculations, multiplicity/alpha adjustments, and statistical methodology sections for moderate to high complexity studies.
• Provide randomization materials including randomization schedules and treatment kit lists per Allucent's Standard Operating Procedures (SOPs) and the relevant sponsor-approved specifications.
• Working knowledge of SAS® for production and/or validation of datasets and tables, listings and figures (TLFs)
• Develop, maintain, and produce specifications for mapped and/or analysis datasets.
• Prepare statistical analysis plans and TLF mocks for moderate to high complexity studies.
• Execute statistical analysis.
• Ensure the efficiency, quality, and integrity of data reporting through document, data, and output review.
• Provide interpretation of data and reporting of results.
• Review statistical section of the study report to ensure it accurately describes statistical methods and results of analyses.
• Review and/or provide guidance on data management plans, project database structures, case report forms (including annotations), edit checks, data mapping conventions, and other relevant and associated DM and vendor documents.
• Manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process.
• Assist management with the identification of out-of-scope work and change order process.
• Identify project risks and provide solutions prior to impact on deliverables.
• Effectively manage multiple tasks and projects.
• Provide mentoring to junior staff.
• Lead projects, communicate with clients and leads of other functional areas, set Biostatistical (ST) and Statistical Programming (SP) timelines and milestones to achieve timely and quality deliverables, be accountable for the development and execution of SAPs, programming, and other deliverables; work with management to ensure internal resourcing supports timelines.
• Identify and lead departmental initiatives; recommend new tools, and process solutions to enhance and deliver efficiency and quality.

• Actively contribute to staff learning & development within the company.
• May oversee and manage the activities of junior staff.
• Draft and contribute as Subject Matter Expert (SME) in the field of Biostatistics activities to the evaluation/improvement of processes and procedures within the Quality Management System.

• Assure strong long-lasting relationships with (future) key accounts.
• Support in preparation of new proposals.
• Contribute and take part in client evaluations, visits and bid defenses.
• Contribute to other areas of business as required.

Requirements

Qualifications:

• Graduate degree (master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, or healthcare.
• Minimum 8 years of relevant work experience.
• Basic knowledge of GxP.
• GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements.
• Expert knowledge of computer systems, applications and operating systems.
• Demonstrate critical thinking and ana