Associate Director, Biostatistics

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Job description

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

The Associate Director, Biostatisticsposition represents a key role in both project teams and within the department and provides significant technical and scientific expertise, for example, in a Functional Lead role on complex projects.

The Associate Director, Biostatistics is expected to have advanced understanding of advanced statistical methods, keep up to date with innovative statistical approaches (e.g, simulations, adaptive designs, Bayesian statistics) and mentor others in advanced statistical methodologies.

The Associate Director, Biostatistics serves as a subject matter expert on elements of clinical trial design and the implementation of advanced statistical methodologies.

* Responsibilities will include: *

* lead statistical discussions around statistical matters pertaining to clinical trial designs, methodologies, regulatory inquiries and submission strategies,
* serve as functional lead on and across project teams
* lead discussions with client leads
* develop and review input for clinical trial activities (trial design, protocol, CRF, SS, SAP, specifications, randomization, DB lock activities, analysis, programming and validation, regulatory submission documents)
* interact and coordinate with client staff

* review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor
* review financial reports, budget proposals and attend bid defense meetings

* mentor Biostatisticians
* provide leadership for Biostatistics Group in initiatives

* QUALIFICATIONS: *

* Education: * PhD / MS in Biostatistics, Statistics, or related discipline

* Experience: * A minimum of 10 yearsof industry experience

* Skills: *

* Advanced Knowledge of statistical methodology and analytic techniques
* SAS programming skills, R programming skills a plus
* Extensive knowledge of FDA and ICH regulations and industry applicable standards.
* Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
* Ability to handle large volume of complex tasks with minimal supervision
* Excellent oral and written communication skills

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel's human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.