Contract To Perm
We are currently searching for a skilled professional to join a well-known client’s team as a Biostatistician in Cambridge, MA. The incumbent will be working with a cross-functional team as the statistical lead, responsible for statistical activities across multiple studies or compounds, and reporting to the Sr. Director, Biometrics. The ideal candidate is a good communicator, high-energy, self-motivated, and forward-thinking.
- Serve as a biostatistics expert for assigned clinical studies or compound-level activities
- Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
- Conduct statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
- Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
- Author or oversee the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and oversee the development of shells for tables, figures and listings
- Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses
- Design and specify randomization schedules; review and approve test randomization lists
- Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
- Validate the results of key statistical deliverables
- Perform ad hoc and exploratory statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results
- Be accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions
- Address statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs
- Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations
- Contribute or lead standardization and process improvement efforts for Biostatistics function and contribute to cross-functional process improvement efforts
- Represent client regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
- Demonstrated ability and experience in the design, analysis and reporting of clinical trials
- Experience in NDAs, MAAs or other regulatory submissions desirable
- In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
- Knowledge of FDA, EMA and ICH regulations and guidelines
- Proficient in statistical programming (SAS is required and R is a plus)
- Experience with trial design software (e.g., EAST)
- Experience working in rare disease is desirable, but not required
- Ability to concurrently lead statistical efforts for multiple studies
- Understanding of data standards, including SDTM and ADaM
- Adept at overseeing statistical services provided by CRO’s and/or contractors
- Ability to work independently and act with initiative to address issues
- Ability to effectively communicate statistical concepts in a clear and concise manner both written and verbally.
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with client values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion
- Ph.D. in statistics or related discipline with at least five years of experience in the pharmaceutical or biotech industry; for Director level
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.