Remote Director/Sr. Director, Biostatistical Consulting

At AllucentTM, 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. Director, Biostatistical Consulting (SrDBiosC) to join our A-team (office-based*/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. This includes management of direct reports, ensuring appropriate resourcing allocation, and supporting business development and proposal needs. This position contributes to the department, the business unit, and Allucent financial and operational goals. 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. The SrDBiosC is a senior member of BIOSC and supervises according to the organizational chart.

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

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

Must have strong experience in Bayesian designs specifically in oncology studies.

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 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 office-based work policy encourages a dynamic work environment, prescribing a minimum of 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."

#LI-Remote #LI-Hybrid #LI-TCW

Job Type: Remote, Full-Time, Permanent