Senior Director - Biostatistical Consulting

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Allucent

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Drug Development • Regulatory Affairs and Submissions • Clinical Strategy • Cell & Gene Therapy • Rare Diseases & Orphan Indications

1001 - 5000

Description

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. • We are looking for a Senior Director, Biostatistical Consulting (SrDBiosC) to join our A-team (hybrid*/remote). • As a SrDBiosC at Allucent, you are responsible for assisting in the coordination of statistical consulting services within the Biostatistics and Statistical Programming Department. • The SrDBiosC, interacts with the BIOSC team and Allucent biostatistics and statistical programming team members, direct reports, executive leadership, other Allucent functional groups and business units. • This position maintains compliance with relevant SOPs, regulatory guidelines, and client expectations. • The SrDBiosC, provides statistical consulting to sponsors to support clinical program development, protocol development, sample size and endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions • **PLEASE NOTE THAT THIS IS A FULL-TIME DIRECT HIRE OPPORTUNITY ONLY**

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 15 years of relevant work experience • Minimum 10 years of experience in drug development and/or clinical research • Thorough knowledge of GxP • 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 • Broad knowledge of drug development • Ability to simplify complex issues into understandable concepts • Proficient with one or more sample size software packages • Strong technical skills with proficiency in SAS and/or other statistical programming languages • Strong written and verbal communication skills including good command of English language • Collaborative and client-focused • Ability to work in a fast-paced challenging environment of a growing company • Administrative excellence • Strong leadership skills • Effective at problem solving, strategic thinking and conflict resolution • Strong presentation and networking capabilities • Excellent organizational, negotiating and financial skills • Knowledge of SAS • Proficiency with various computer applications such as Word, Excel, and PowerPoint • Strong individual initiative • Excellent attention to detail and commitment to quality • Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors • Ability to effectively manage multiple tasks and projects • Reputation as a leader with sustained performance and accomplishment

Benefits

• Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/hybrid* working depending on location • Leadership and mentoring opportunities • Participation in our Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via GoodHabitz and internal platforms