We are currently searching for a skilled professional to join a well-known client’s team as Biostatistician in Boston, Massachusetts. The Biostatistician role will report to the Director of Biostatistics and will provide statistical support and programming support for clinical trials. As the Biostatistician contributes to the development and improvement of standards for statistical activities, their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Apply knowledge of statistics, statistical programming and pharmaceutical regulations to fulfill primary duties
- Prepare and review statistical analysis plans (including shell tables, listings, and figures)
- Prepare and review programming specifications used in creating analysis datasets, tables, listings, and figures
- Perform efficacy and safety analyses for clinical trials data
- Participate in validation and quality control of statistical output
- Contribute to the development and improvement of standards for statistical activities
- Work closely with data management and database teams in the development of CRFs, database specifications, and database validation checks
- Implement and support CDISC (both SDTM and ADaM) and other regulatory standards
- Perform other duties as requested by management
- Assist with creating, revising, and reviewing SOPs as needed
- Minimum 1-4 years of experience in analyzing clinical trials data (at least 1 year in a pharmaceutical or CRO setting)
- Knowledge of basic statistical concepts
- Strong SAS programming skills, including data manipulation and statistical analysis procedures
- Experience with Word, Excel, and PowerPoint
- Experience in providing statistical support and SAS programming support for clinical trials (including participation in SAP development, preparing and reviewing programming specifications, analyzing data and reviewing case report forms (CRFs), and database structures)
- PhD or Master’s degree in Statistics or a closely related field
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.