Director Of Biostatistics

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Director

Posted 4 months ago
Job details

Overview


The Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and expertise for a product line through the entire development process. This role provides statistical input into the drug development plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This role also leads and contribute to statistical innovation activities.


Responsibilities:


Lead one or several indications corresponding to one or several compounds in development.

Represents Biostatistics as a member of cross functional teams, accountable for statistical aspects of clinical development plans, studies, submission activities and regulatory interactions.

Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.

Lead or contribute to statistical innovation activities including innovative design, advanced analytics, data visualization and template development.

Independently undertake new and highly complex issues requiring advanced analytical thought

Foster productive collaboration across Biometrics and cross-functionally, while effectively communicating with key stakeholders.

Lead and contribute to departmental projects

Provide technical guidance and mentoring to Junior statisticians.


Qualifications:


A Ph.D/MS. in Statistics or Biostatistics with more than 10 years of pharmaceutical experience

Strong knowledge of pharmaceutical environment and broad experience with multi-phase development.

Strong knowledge and in-depth understanding of advanced statistical concepts and techniques applicable to Clinical Research

Strong project management, interpersonal and communication skills

A track record of successful contribution to submission dossiers (IND, CTD) and interactions with regulatory agencies or other external stakeholders

Experience with NDAs, and MAA’s is highly desired

Ability to influence and to contribute to the advancement of innovative statistical methodology

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Director

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 11, 2024
Company Overview
Penfield Search Partners Ltd
Penfield Search Partners Ltd

Current Openings: 0

Penfield Search Partners Ltd. is an executive recruiting firm dedicated to personalized recruitment services; specializing in three specific areas: ~ Property and Casualty Insurance ~ Pharmaceutical, Biotech and Life Sciences ~ Contract Staffing Solutions Our Insurance principals, Karen McCorkindale, Andy Davis and Sean deGroot have recruited together for nearly two decades; our Pharmaceutical and Life Sciences practice is headed by principals Kyle Diamond, Kevin McGrath, and Barbara Day with over 35 years of combined industry expertise. Property and Casualty Insurance - Our relationships include carriers, retail and wholesale brokers, corporate risk buyers and consultants, as well as reinsurance entities. In addition to our broad capabilities, we are recognized as the “go to” firm in the management and professional liability niche markets. Pharmaceutical, Biotech and Life Sciences – Our relationships include many of the leading pharmaceutical and biotech companies nationwide. Our strength is our niche expertise in sales analytics, marketing sciences, forecasting, market research, marketing, health economics, outcomes research, clinical statistical programming, biostatistics, and market access. We are a seasoned team of specialists with knowledge of the influencers, thought leaders and decision makers in the industry. Contract Staffing Solutions - our newly launched group is headed by Directors Michelle Meyer and Angie Foster. INSURANCE Property and Casualty, Risk Management, Underwriting, Brokerage, D&O and E&O PHARMACEUTICAL Commercial - Market Research, Marketing, Marketing Science, Sales Analytics, Forecasting HEOR – Real World Evidence, Outcomes Research, Field Outcomes, Market Access Programming – Statistical Programming, Data Standards, Database Programming Statistics – Biostatistics, Pre-clinical/Discovery, Manufacturing CONTRACT STAFFING SOLUTIONS Biostatistics, Statistical Programming, Data Standards, Database Programming, Data Management
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