Clinical Research Statistician – NDA Submission

By | December 19, 2024

Clinical Research Statistician - NDA Submission

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Job ID: 9668336

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Thousand Oaks, CA, US

Scientific

Unspecified

Full Time, Temporary

Up to: $87.10/Hour (commensurate with experience)

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Thousand Oaks, CA, US

Up to: $87.10/Hour (commensurate with experience)

Experienced (Non-Manager)

Full Time, Temporary

Biotechnology/Pharmaceuticals

On-site

Scientific

Unspecified

First Shift (Day)

Apply Now Applied

Job details

PLEASE NOTE: Must be legally authorized to work in the United States for any employer without sponsorship. For immediate consideration, please apply.

Kelly® Science & Clinical is seeking a remote Ph.D. Level Statistician for a temporary position (with potential to extend/convert) at a leading client in Thousand Oaks, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:
$95-115.00+/Hour (commensurate with experience)

Overview:
Our client is seeking a highly skilled Ph.D. level Statistician for a contract role. The ideal candidate will have extensive experience, specialized knowledge in statistical methodologies, and a strong ability to implement statistical techniques.

Schedule:
Monday – Friday, 1st/Day: Standard Hours (weekend work available but not required)

Responsibilities:

  • Perform advanced statistical analyses and provide interpretations.

  • Collaborate with cross-functional teams to support regulatory submissions.

  • Develop and validate statistical methods and models.

  • Ensure compliance with regulatory requirements.

Qualifications:

  • Education: Ph.D. in Statistics or a related field.

  • Experience: At least 8 years of professional experience in statistical analysis.

Key Requirements:

  • NDA Submission Experience: Proven track record in preparing and submitting New Drug Applications (NDA).

  • EMA Submission Experience (a plus): Experience with European Medicines Agency (EMA) submissions is advantageous.

  • Rare Disease and CNS Experience (a plus): Familiarity with rare diseases and Central Nervous System (CNS) statistical analysis is beneficial but not mandatory.

  • Statistical Strength: Strong expertise in statistical methodology and its implementation.

What Happens Next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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