We are currently searching for a skilled professional to join a well-known client's team in Mount Airy, Maryland as a Biostatistician. The remote Biostatistician role will assist in the development and support of innovative approaches to optimize the conduct and science of clinical trials, including use of synthetic control arms. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Provide statistical expertise to research in statistical methods, development of statistical sections of protocols or analysis plans, scientific publication or presentation, and data analyses for individual projects or larger synthetic controls program
Review patient-level data from thousands of previous clinical trials in the Medidata Enterprise Data Store (MEDS) to assist with the statistical expertise
Collaborate with members of the data standardization team and other groups to assist in evaluating the accuracy of standardized historical data for each project assigned
Present at internal or external meetings
Communicate findings through written reports
Minimum of 3 years of related experience in the pharma and/or regulatory (e.g. FDA) context analyzing and interpreting clinical trials data required
Strong ability in the design, analysis, and interpretation of clinical trials and clinical research
Excellent written and verbal ability, including the ability to be persuasive to a technical or non-technical audience
Strong statistical skills
Knowledge of typical drug development processes, including the regulatory interactions expected at each phase of development and the level of evidence generally required for approval of a new medical product
Ability to work in a fast-paced environment and work on multiple projects at the same time
Oncology therapeutic area experience desired
Minimum of PhD in Biostatistics or 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.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.