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**
In this role your key tasks will include:
Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions
Provide statistical consulting for complex and/or novel statistical analyses
Provide statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams
Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable
Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study
Provide senior reviews of statistical documents, data, and outputs for studies of all complexities 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 studies of any complexity level
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
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 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
Function as the 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 high complexity and/or of high value.
Identify high-risk or high-impact deliverables and assign appropriate oversight
Lead and manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process
Collaborate with and verify open communication with other functional areas and business units
Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams
Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients
Provide key input into project proposals and budgets
Establish positive relationships with current and future clients
Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
Monitor and assure client satisfaction on existing projects for biostatistics and statistical programming
Contribute to BIOSC, BBU, and corporate marketing activities via blogs, webinars, white papers, and other publications and presentations
Contribute to other areas of business and assignments as required
Requirements
To be successful you will possess:
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
Benefits of working at Allucent include:
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
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
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Equal Employment Opportunity and Affirmative Action. Allucent (US) LLC is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote qualified persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, marital status, military and/or veteran status, or disability. Furthermore, to the extent required by applicable laws and/or Executive Orders, we take affirmative action to ensure that minority group individuals, females, disabled veterans, recently separated veterans, other protected veterans, Armed Forces service medal veterans, and qualified disabled persons are introduced into our workforce and considered for promotional opportunities. Allucent (US) LLC is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act - ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286.
