Head of Biostatistics and Data Management
Our client is a biotechnology company. They have asked us to assist them in a search for a Head of Biostatistics and Data Management.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Contributes to the strategic planning of clinical development programs.
- Is responsible for ensuring the application of both traditional and emerging statistical methods, modeling, and simulation techniques.
- Is responsible for data acquisition and statistical design of protocols, Statistical Analysis Plans, and clinical study reports writing that support the development and execution of clinical development strategies.
- Works closely with other clinical development leaders to develop optimal strategies to grow the portfolio and advance development programs.
- Develops innovative analytic strategies for clinical trial data collection, analysis, and presentation for both safety and efficacy data.
- Communicates and resolves all statistical-related issues with DSMBs, FDA and other health regulatory authorities.
- Ensures high quality data by defining consistent biostatistical processes across all clinical studies and by defining and improving data interfaces between all parties participating in a clinical trial.
- Oversees data management activities, including vendor data base interfaces and exchange.
- Effectively executes and oversees all Data Science-related activities, timelines, and deliverables.
- A Master’s degree in Biostatistics, Statistics or related field of study is required. A PhD is preferred.
- Requires significant years of experience leading biostatics activities in the pharmaceutical industry.
- Must have experience in CNS therapeutic area. Experience in neurodegenerative disease a plus.
- Experience overseeing data management activities is required, in particular data base reconciliation.
- Must have a strong interest in growing an expertise in Alzheimer’s and Parkinson’s diseases.
- A broad and extensive knowledge of theoretical and applied statistics is required.
- A basic understanding between disease modification and symptomatic effects in neurodegenerative diseases is preferred.
- Requires an advanced knowledge of statistical analysis methods in clinical development, including but not limited to adaptive trial design approaches.
- Experience in management and oversight of CROs is preferred.
- Requires working knowledge of CDISC standards.
- Knowledge of and experience with MedDRA data dictionaries is required.
- Must have excellent written and verbal communication skills.
- Must be creative and able to work independently and collaboratively.
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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