Sr. Biostatistician

Location
Emeryville, CA, United States
Posted
Oct 12, 2019
Ref
odhe4fww
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
PRIMARY PURPOSE OF POSITION:

This position is responsible for providing statistical support for Santen clinical projects under the direction of project Lead Statisticians. Major responsibilities include: Prepare and review of Statistical Analysis Plans; Analyze clinical trial data with basic statistical methodologies using SAS; Generate randomization schedules per specification; Review eCRFs; Provide statistical support to Programming; Review of Clinical Study Reports; Perform QC tasks, including validating statistical outputs in study-related reports.

MAJOR DUTIES OF POSITION:
  • Build up the pharmaceutical industry and drug development knowledge, especially in the area of ophthalmology.
  • Participate in protocol development by providing sample size calculation and justification and statistical considerations;
  • Review eCRFs to ensure their design meets the protocol criteria and captures all data required to support a quality database and planned analysis;
  • Generate and review randomization schedule(s);
  • Work closely with SAS programmers and Study Statistician to create SDTM and ADaM specifications and datasets;
  • Perform plausibility checks on data and take appropriate action to handle implausible values during analysis;
  • Generate and review standard tables, listings, figures to ensure accurate and appropriate analysis and results for clinical studies;
  • Conduct and participate in validation of project deliverables as necessary;
  • Perform statistical analysis and prepare corresponding sections of the Clinical Study Report;
  • Ensure proper study closeout by documenting and archiving study-related materials;
  • Provide statistical support for other functions to meet their needs for clinical research and development purposes;
  • Provide statistical support for any presentations and publications;
  • Provide statistical support as needed for reports required by the Data Monitoring Committee;
  • Participate in clinical research and development activities organized to improve operational and statistical analysis procedures;
  • Attend meetings and job-related training sessions when requested and as appropriate;
  • Other duties may be assigned as needed.


KNOWLEDGE AND SKILL REQUIREMENTS:
  • Ph.D. in Biostatistics or Statistics with up to two (1-2) years' experience in the pharmaceutical industry, or MS in Biostatistics or Statistics with two to five (2-5) years' experience in the pharmaceutical industry; A Ph.D. level statistician with ophthalmic pharmaceutical industry experience is preferred.
  • Ability to learn and apply the knowledge of FDA statistical guidelines.
  • Solid understanding of mathematical and statistical principles;
  • demonstrated proficiency in SAS; Knowledge of other statistical software is a plus.
  • Good communication skills. Ability to interpret statistical methodologies and findings to non-statisticians and make effective presentations to small groups such as project teams.
  • Ability to work effectively and independently in a team environment.
  • Good planning and problem-solving skills

PHYSICAL DEMANDS:


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to
  1. Must be able to spend a considerable amount of time at the computer
  2. Must be able to stand, kneel and stoop for filing
  3. Must be able to use the telephone and speak with internal and external individuals
WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISOR:

Director, Biostatistics

EMPLOYEES SUPERVISED/#:

None (Individual Contributor)

SANTEN INCORPORATED IS AN EQUAL OPPORTUNITY EMPLOYER

NO RECRUITMENT AGENCIES, PLEASE