Senior Director, Biostatistics
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Senior Director, Biostatistics.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Is responsible for the overall statistical strategy in collaboration with key clinical development functions.
- Provides support to the clinical development team to enable robust study design and execution.
- Contributes to clinical protocol development, including ownership of statistical sections of the protocols.
- Authors statistical analysis plans and specifies mock tables, listings, and figures.
- Reviews CRF designs to ensure data collection meets the objectives and requirements of statistical analyses.
- Specifies randomization schedules and tests their implementations.
- Works with programmers or CROs to generate tables, listings, and figures.
- Performs ad hoc analyses as needed.
- Contributes to the review, synthesis, and interpretation of analysis results.
- Contributes to the clinical study reports, including authoring of statistical sections and interpretation of analysis results.
- Supports regulatory submissions, including any required face-to-face engagements with regulators, and post-submission activities.
- Supports the preparation of publications, including manuscripts, posters, and abstracts.
- Provides requirements and oversight to statistical programmers.
- Provides oversight of statistical activities at CROs.
- A PhD in statistics or a related field with at least four years of relevant clinical trial experience or an MS in statistics with at least eight years of relevant clinical trial experience is required.
- Must have experience in the design, analysis, and reporting of clinical trials.
- An in-depth knowledge of statistical methods for oncology clinical trials is required.
- Requires the knowledge of FDA and ICH regulations and guidelines.
- Experience with supporting Phase III oncology trials is desirable.
- Experience supporting regulatory interactions at various phases of oncology drug development is desirable.
- Must be proficient in statistical programming (e.g., SAS or R).
- Requires the ability to concurrently support multiple studies.
- Must be a team-oriented individual with a proven ability to thrive as a part of cross-functional efforts.
- An understanding of data standards, including CDASH, SDTM, and ADaM is required.
- Must have strong interpersonal, communication and writing skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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