Senior Biostatistician, Pharmascent, San Francisco Bay Area (North Bay)

Type: Contract (possible contract-to-permanent)

The overall function of Biostatistician is to provide statistical support to new drug development project teams through actively participating in protocol development (study design, sample size justification, and safety/efficacy analysis methods) and developing a statistical analysis plan and programming specifications in preparing a clinical study report (CSR) or publication.

RESPONSIBILITIES:
• Participate in new drug development programs as a Subject Matter Expert (SME) in statistics area.
• Keep abreast with advanced statistical analysis methods and results/data presentation formats of clinical data.
• Collaborates with Medical Monitor, Clinical Research Associate (CRA), Medical Writer, Clinical Data Management (CDM), and Statistical Programmer in developing a clinical study protocol, case report forms (CRFs), and edit checks.
• Provides a sample size based on the specification provided by Medical Monitor.
• Develops a statistical analysis plan for a clinical study or publication.
• Develops analysis specifications for Statistical Programmer and reviews/verifies analyses and programming codes for quality assurance.
• Participates in development of standard reporting programs for clinical studies.
• Participates in development of standard CRFs for clinical data collection.
• Participates in regulatory submissions including CSR, IND safety update, Annual Report/PSUR, and integrated summaries of safety and efficacy in NDA and BLA
• Ensures the quality of data and accuracy of analyses in regulatory submissions (e.g., CSR) or publications.
• Develops SOPs, guidelines, and template.

EDUCATION:
Minimum educational degree is an MS in Statistics, Biostatistics, or Biometrics.
Preferred educational degree is a Ph.D in the same areas described above.

REQUIREMENTS:
• A minimum of 4 years for Ph.D (6 years for MS) work experience in the Pharmaceutical/Biotech industry.
• Must be knowledgeable of statistical methods in clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS), and regulatory regulations/guidelines.
• Preferred to have worked on electronic NDA and/or BLA submissions via e-CTD.
• Must be able to complete complex tasks in a timely manner with a minimal supervision.
• Must be highly motivated and able to take initiative.
• Must be able to work well under pressure and shifting priorities independently and as a team member.
• Excellent oral and written communication skills.


Please contact Rebecca Roe at rroe@pharmascent.com to inquire about this opportunity. I can be reached via phone at 925-627-4954. I look forward to hearing from you!

**If this is not a fit for you or you are not interested, I greatly appreciate qualified referrals. We offer an excellent referral bonus program. It pays to network!

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Senior Biostatistician, Pharmascent, San Francisco Bay Area San Francisco Bay Area (Peninsula)

Type: Permanent FTE

Responsibilities:
-Works cross-functionally to meet project deliverables and timelines for statistical data analysis and reporting.
-Provides statistical consultation on trial design and study endpoints.
-Calculates sample sizes and authors statistical analysis plans.
-Utilizes knowledge of Regulatory requirements and guidance documents to provide statistical advice with respect to creating a clinical development program.
-Uses knowledge of literature to provide data analysis and presentation methods to support publications/presentations.
-Take a leadership role on assigned departmental strategic initiatives.

Requirements:
-Requires a PhD in Biostatistics or equivalent. Master’s candidates will only be considered if they have significant Pharmacokinetics (PK) experience.
-Significant industry experience in the statistical analysis of biomedical data using SAS software.
-Excellent verbal and written communication skills and interpersonal skills are required.
-Anticipates change and reacts quickly and proactively to accommodate business need.
-Work collaboratively with others to gain common understanding and insight.


Please contact Rebecca Roe at rroe@ascentsg.com to inquire about this opportunity. I can be reached via phone at 925-627-4954. I look forward to hearing from you!

**If this is not a fit for you or you are not interested, I greatly appreciate qualified referrals. My company will be happy to pay you a referral bonus if someone you send our way is hired by our client for this position.

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