Sr. Biostatistician (North America)

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 Sr. Biostatistician (SrBios) to join our A-team (hybrid*/remote). As a SrBiosat 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 simple to moderately complex studies, and provides senior review of statistical documents and outputs. This position may assist in the programming of datasets and outputs using SAS®. The SrBios will regularly interact with other members of the Allucent biostatistics project team and will interact with clients when leading a study. 
The SrBios 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 simple to moderate studies  
Familiarity with complex statistical methods and concepts 
Provide senior reviews of statistical documents, data, and outputs for simple to moderately complex studies 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 simple to moderate studies 
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 
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 simple to moderate 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 supporting or 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 moderate to high complexity. 
Other responsibilities as needed.
Requirements
To be successful you will possess:
Bachelor’s degree; master's degree preferred, in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare  
Minimum 4 years of relevant work experience  
Good knowledge of GxP 
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 
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 
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 .
“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.”