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Programmers Analyst
Key words
SAS, C++, JAVA, PROGRAMMING, STATISTICS, MATHEMATICS
Major Required:
IT preferred. Other majors like Mathematics, Statistics, Engineering, Physics are acceptable if have strong IT (ORACLE, JAVA, C++) and English background.
Essential Responsibilities
1. Develops SAS programs to produce data listings and Case Report Form Tabulations (CRT)
2. Builds standard tabulation datasets
3. Creates derived or analysis datasets
4. Develops SAS programs to implement statistical analyses to generate tables, listings and figures as specified in the statistical analysis plans
5. Performs validation of and quality assurance aspects of all SAS programming activities
6. Develops SAS programs for other needs
7. Consults on other statistical programming tasks, such as support for CRF design, database development, data validation plan and blinded data review.
Qualifications/Requirements:
1. Excellent English communication skills, can work independently with native English speaker.
2. Must have proficient SAS or Oracle SQL programming skills, if have neither of these two, must have a demonstrated capabilities to program in advanced languages: like C++, JAVA and/or assembly language.
3. Must possess great interpersonal capabilities and can work with people from different cultures. Have ability to construct good relationship within a team environment.
4. IT background preferred. Candidates from other majors with strong records and strong intention to be a programmer analyst are also welcomed.
5. Must have a bachelor degree, higher degrees are preferred.
6. Knowing drug development procedures and FDA/SFDA regulations is a plus.
7. Oversea working experience in IT, Statistics, Math is a plus.
8. If apply for Sr. or Manager level position , must also have broad clinical trial background and have a knowledge of government regulations on drug development procedures, exempt for other levels.
Biostatistician
Responsibilities
Performs statistical activities for given clinical trials involving drugs, biologics and medical devices; provides statistical support to the project team; lead a biostatistics project tem.
Participates in clinical trial protocol development, including sample size and statistical power calculation and contribution to writing appropriate protocol sections.
Generates randomization schedule and participate drug repackage/relabeling activity.
Develops statistical analysis plan (SAP) including table shells design.
Reviews protocols, SAP or other study documents developed by other statistician(s) or consultant(s) and provides comments.
Represents statistical team at project team meetings and provides updates to project team on status of tasks.
Writes statistical analysis report (SAR) and participates in clinical study report (CSR) writing.
Performs other statistical review, such as case report form (CRF) design, database development, data validation plan and blinded data review report.
Where applicable, provides input and review the specifications of the programs that produce the tables, listings, figures, and/or analysis datasets.
Reviews and validates programs according to established departmental or partner’s procedures.
Performs other duties assigned by manager.
Qualifications
An advanced degree (Ph.D. or M.S.) in biostatistics, statistics or related field
A minimum of 1 years experience of statistical and/or statistical programming applied to drug or medical device development
Knowledge, Skills and Abilities:
Good writing skills required to be able to write sections of protocols, statistical reports, clinical study reports, and randomization plans
Good SAS® programming skills.
Being familiar with CDISC data standards is a plus.
Experience of international drug development in a multicultural environment is a plus.
Ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality.
Be knowledgeable in all aspects of the drug agencies (e.g. FDA, SFDA) regulations and requirements governing the conduct of drug and medical device studies including, but not limited to, GCP and ICH requirements.
Good communication and interpersonal skills.
Be able to make effective presentations in public settings.
Proficient working in a PC/Windows environment.
Sufficient written and oral English communication skills.
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