Biostatistician II Temp

Acorda Therapeutics
Oct 06, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time

The Biostatistician II temp is responsible for developing, modifying and evaluating statistical elements of clinical trials and basic research. In addition this individual evaluates databases and statistical analyses programs and interacts closely with the clinical department.

There is no relocation for this position.

* Essential Duties and Responsibilities include the following. Other duties may be assigned.

* Works as a member of a team to design and/or review protocols, case report forms, and statistical analysis plans.

* Reviews protocols and case report forms for soundness of trial design.

* Develops statistical analysis plans including analysis files and report specifications.

* Supports creation of publication material from a statistical perspective.

* Performs complex statistical analyses, interprets statistical results and helps prepare study reports including summaries for FDA submissions.

* Assists with clinical study design and protocol amendments.

* Performs relevant sample size calculations.

* Authors or reviews statistical sections of clinical study reports.

* Writes complex statistical plans, protocols and reports.

Education and/or Experience:

* Master's degree in Biostatistics, Statistics, Applied Mathematics or related field required.

* Ph.D. in Biostatistics, Statistics, Applied Mathematics or related field preferred.

* Minimum of three years of clinical trial experience.

* Prior experience in either pharmaceutical or biotechnology industries preferred.

Supervisory Responsibilities: None


* Must be able to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

* Knowledge of statistical and clinical trial methodology is required.

Computer Skills:

* Must be proficient in MS Office Suite.

* Must have prior experience with SAS Programming.

Certificates, Licenses, Registrations: none required

Other Skills and Abilities:

* Attention to detail with high quality outputs.

* Must have excellent verbal, written and communication skills.

* Ability to work in a team environment with medical personnel, clinical monitors, data managers, clinical programmers, statisticians, and statistical programmers.

* Ability to prioritize, multi-task, and maintain attention to detail.

* Strong analytical skills and ability to gather and understand client requirements.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

No specific physical demands.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

No specific work demands.

* To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.