At Advanced Clinical, we’re excited to share with you a great opportunity at a growing organization committed to clinical excellence for the position of Biostatistics Manager. The Biostatistics Manager will be located in Princeton, New Jersey, and will be committed to providing statistical support to drug development programs, in training, mentoring, monitoring, and supervising of a biostatistics team. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!
- Coordinate teams and assignments of resources across projects
- Monitor all projects to ensure they stay on target
- Ensure overall quality biostatistics deliverables
- Provide statistical input to study protocols
- Monitor internal and CRO project activities including timelines, deliverables, and availability of resources
- Interpret study results and write (or at least QC and review) statistical summary reports of study results
- Assist in writing relevant sections of the clinical study report
- Participate in pre-IND and NDA activities
- Create, revise, and review SOPs to recognize and prevent potential regulatory issues
- Apply knowledge of statistics and drug development to fulfill primary duties
- Implement and support CDISC, ICH, and other regulatory standards
- Review protocols, CRFs, and database structures
- Prepare, review, and approve statistical analysis plans to ensure that appropriate statistical analyses are proposed and implemented
- Provide statistical support for Independent Data Monitoring Committees and interim analyses
- Ensure the accuracy, quality, and appropriateness of the statistical tables, listings, graphs, and derived datasets for Clinical Study Reports and for other regulatory filings, including IND annual reports and Integrated Summaries of Safety and Efficacy
- Communicate statistical concepts and arguments to colleagues, clients, and regulatory agencies
- Utilize SAS programming to perform efficacy analyses and validate important data derivations when necessary
- Minimum 1-3 years of experience in pharmaceutical or biotechnology industries with broad knowledge of biostatistics
- Oncology experience required
- Experience with SAS programming preferred
- Experience with health authorities, including discussions/negotiations in filing strategies preferred
- Knowledge of multivariate analyses and Biomarker analyses preferred
- Ph.D. Degree in Statistics required
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.