Principal Biostatistician (North America) at Allucent in Cary, North Carolina

Job Description:

Allucent


Location: Cary, North Carolina, United States Toronto, Ontario, Canada

Department: Biometrics Business Unit (BBU)

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 Principal Biostatistician (PrBios) to join our A-team (hybrid*/remote). As a PrBios at Allucent, you are responsible for supporting 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. The PrBios is a member of the Biometrics staff. .

In this role your key tasks will include:

• 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 a study of any complexity
• Familiarity with complex statistical methods and concepts
• 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 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
• Provide input and 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 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
• Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value.

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 8 years of relevant work experience
• Good 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

• 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
• Knowledge of SAS
• Collaborative and client focused
• Ability to effectively manage multiple tasks and projects
• Strong leadership skills
• Effective at problem solving, strategic thinking and conflict resolution

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 enriching 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
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

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.”

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.

PI241021811

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