Job Title: Director, Biostatistics (Oncology Indication Lead)
Full time permanent - Direct with a global pharmaceutical company
Location: Remote, US Based only, must be located in EST or CST time zones.  Must be able to travel to NJ quarterly. 

Prior experience as a Statistician indication lead for an Oncology trial is required. 

Job overview 

Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems.

Responsibilities

• Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire project. Act as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies’ requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product.
  Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted. Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD).

• Drug Development Strategy: Provides input to the entire development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies’ requirements for countries and regions the drug is to be submitted.
  Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.

• CRO / Vendor Oversight: Participates in drafting request for proposal for CRO selection. Reviews and negotiates baseline budget and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high quality deliverables.

• Global Health Authority Interaction / Negotiation: Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities meetings as needed.

• Global BDO Strategy to Improve Drug Development: Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)

• PhD in statistics or biostatistics required

Experience Qualifications

• 7 or More Years of relevant experience in the pharmaceutical industry required

Travel
Ability to travel up to 20% International travel required

#M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.