Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Director of Biometrics- USA, San Francisco Bay Area

Company: RBW Consulting
Location: San Francisco Bay Area
Reference: AL-Pharm-DIBO-USA
Closing Date: 13 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Come join the team to be part of the change, be a part of the growth and await the opportunities within.

Requirements:

 
This company has built a broad portfolio of both small and large molecule candidates with the hope and potential to address diseases of which have high medical needs. Currently, there are no approved therapies for these needs, but this company looks to change that.

 

Experienced Biostatistician with drive, ambition and a willingness to work independently with advanced technical and communication skills.

Working with and reporting to the Senior Director of Biostatistics.

This role involves working as a program statistical lead as well as providing biostatistical support on designs of projects and conduct of clinical studies and providing technical leadership.

Participate in the evaluation, interpretation and reporting of study results in regulatory submissions to FDA as well as other Regulatory agencies- performing statistical analysis and developing tracking systems for data quality assurance.

The candidate must manage the efforts across therapeutic areas and identify, improve and implement departmental standards, applications as well as processes and training.

 

Responsibilities

Within this role, it is important to lead in product level tasks including regulatory interactions and filing, ensure statistical integrity and contribute strategically to the supporting projects from statistics perspective.

Working on study level tasks from a statistics perspective. This would include contributing in study design and sample size determination, reviewing statistics sections in the protocol, SAP and DMC charter.

Create and review study randomization files-. This will include developing TLG shell, specification reviews, CRFs and other study documentations.

Collaborate within biometrics teams as well as with cross-functional teams to reach product deliverables and timelines for statistical data analysis and reporting.

Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements

Independently conduct analyses suggested by the data; Propose new statistical methodological approaches to improve the efficiency of study results

Contribute in developing standards and research in advanced statistical methodologies

Review regulatory documents or scientific publications

Advise and mentor junior team members

 Requirements

  • PhD in Statistics or Biostatistics
  •  A minimum of 8 years with PhD with post-graduate experience within clinical trials
  • A minimum of 11 years for Msc with experience with clinical trials
  • Experience in NDA / BLA / MAA activities as a key contributor from a statistics perspective and direct involvement in regulatory interaction
  • Experience as product lead statistician and contribute in strategy discussion in cross functional settings.
  • Experienced in managing and leading multiple products and studies and being able to prioritize
  • Familiar with study level work while authoring SAP and TFL specification
  • Experience with ICH guideline, FDA / EMA / other regulatory authority guidance
  • Experience in statistical methods; analyzing longitudinal data is preferred
  • Excellent interpersonal and communication skills.
  • The ability to translate statistical concept to program strategies as well as organise and prioritise.
  • Problem solving skills and multi tasking; demonstrating the ability to prioritize tasks according company timeline.
  • Knowledge in CDISC including SDTM, ADaM, and controlled terminologies and has used SAS and R.

 

To find out more about this fantastic opportunity please contact Amanda Leslie at RBW Consulting.

At RBW Consulting LLP, every one of our consultants has the benefit of five years’ experience in helping Pharmaceutical Professionals find the jobs they are looking for in the industry.

With unrivalled industry knowledge and excellent links across the world, we would be delighted to speak with you about the role you are looking for.

 

Apply for this job: Director of Biometrics- USA, San Francisco Bay Area

Contact Information:

Address:  Brighton
Southdown House, 130a Western Road, Brighton BN1 2LA
BN1 2LA
England
Tel:  01293 584 300

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.