ProClinical is recruiting for an exciting new permanent position as an Associate Director/Director of Biostatistics based in Cambridge, MA. The ideal candidate will be working with a cross-functional team as the statistical lead, responsible for statistical activities across multiple studies and/or compounds, and will report to the Senior Director of Biometrics. Additionally, the ideal candidate is a good communicator, high-energy, self-motivating and forward-thinking. Experience working with rare disease is preferred but not required.
- 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 the client regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners.
Skills And Requirements
- Ph.D. in statistics or related discipline with at least five years of experience in the pharmaceutical or biotech industry; for Director level, PhD in statistics or related discipline with at least nine years of experience in the pharmaceutical or biotech industry.
- Demonstrated ability and experience in the design, analysis and reporting of clinical trials
- Experience in NDAs, MAAs or other regulatory submissions preferred.
- 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 preferred).
- Experience with trial design software (e.g., EAST).
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mike Froggat at (+1) 6467689727 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.