Our client is revolutionizing the pharmaceutical industry and is looking to hire a highly skilled professional for the role of Senior Biostatistician in Cambridge, Massachusetts. The right candidate will support all statistical and statistical programming activities that enable the development and execution of the integrated companion diagnostics strategies for Company programs. The company has one of the strongest reputations in the clinical business to add to your career and resume.
- The Statistician will provide statistical and data-analytic support for the design and subsequent analyses of molecular and clinical data from design verification, analytical performance characterization and clinical validation studies in conjunction with registrational clinical trial assays (rCTA) and IVD CDx device development and registration
- Manage resources and priorities
- Candidates with several years of experience will also be expected to help mentor junior team members
- Establish and maintain excellent collaborative relationships with internal and external scientific groups involved in analysis
- Establish and maintain sound working relationships and effective communication within Biomarkers and Diagnostics Biometrics (BDB) and BDM
- Follow processes and adhere to Company and project specific standards as well as Health Authority requirements (SOPs, BGs, Master Analysis Plan, GCP, and regulatory guidelines)
- A minimum of two years of relevant work experience
- Expertise in SAS programming is a must Complete understanding and wide application of technical principles, theories and concepts in the field of (companion) diagnostic Statistics
- Familiarity with methods for the design, optimization, verification of IVD devices under design control (e.g. DFSS, DoE, RSM), is desirable
- Familiarity with Oncology Statistics or regulatory activities would be advantageous
- Experience in Software Engineering a plus
- Proven knowledge and expertise in statistics and its application to analyze laboratory data, data mining and/or bioinformatics and their applications to clinical trials
- Experience with a wide range of advanced statistical methods
- Knowledge of statistical software packages (e.g. SAS, R, JMP)
- Fluent English (oral and written)
- MS in statistics with 2+ years relevant work experience or PhD in statistics with no work experience
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.
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