Principal Biostatistician

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 .

“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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