Skip to main content

This job has expired

You will need to login before you can apply for a job.

Associate Director, Biostatistics

Employer
Nektar Therapeutics
Location
San Francisco, CA, United States
Start date
Jun 24, 2021

View more

Discipline
Science/R&D, Biostatistics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Position Overview

Nektar has an exciting opportunity for an Associate Director, Biostatistics to join their team.

Directs the design, development, modification and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials. Serve as a lead statistician on clinical studies and provide senior level statistical input to BDM department. Maintain the statistical and analytical integrity of clinical trials data analyzed by in-house resources or external vendors. Actively participate in writing statistical sections of protocols and preparing statistical analysis plans.

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules, and performance requirements are met. Regularly interacts with senior management or executive-levels. Communicates with various internal and external audiences such as, scientists, engineers, clinicians, quality staff and partners as required. Provides strategic input on protocol design and clinical trial data analysis, develops statistical analysis plans and statistical methodology sections of planned protocols, oversight of programming support and of any outsourced biometric responsibilities. Provides a statistical interface with Regulators, crafting responses to relevant Regulatory questions, providing assistance in the generation of high-quality clinical trial data to aid in programmatic decision-making. Plays a statistical leadership role in the support of Regulatory filings and submissions. Contributes to the development of charters for DSMBs and Endpoint Adjudication Committees and may serve as a sponsor liaison with these committees. Manages the development, review and approval of relevant SOPs, and CRF design. Ensures adequate procedures and processes are in place for the biostatistics group and that data set and analyses are stored according to established company policies and all relevant regulatory mandates. Prepares and provides written reports, presentations and publications as required. Collaborates with other functional lines including Regulatory, Clinical Sciences and Clinical Operations. Serves as point of contact for biostatistical support and data management services provided by external vendor. Identifies, develops and delivers internal biostatistics training courses as required. Manages the utilization of resources and identifies when and where additional resources may be needed to provide effective biostatistics support to customers. Responsible for providing regular performance feedback, development and coaching to direct reports.

A minimum of a Bachelors degree in a statistics discipline is required. An advanced degree in a statistics discipline is strongly preferred. Equivalent experience may be accepted. A minimum of 10 years experience in statistics related to the pharmaceutical industry is required. A minimum of 8 years previous management experience is preferred. Previous experience working in a quality regulated environment with a thorough understanding of cGCPs is highly preferred. Must have a thorough understanding of SAS programming. Must be able to demonstrate expert knowledge of statistical principles and concepts. Must be able to demonstrate strong project management skills. Previous experience designing and delivering presentations/trainings is required. Strong oral and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Experience working in a team-focused environment is preferred. Excellent computer skills are required. Must be detail oriented. Must have an ability to create and manage internal and external technical and business relationships, representing the company in a highly professional manner.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

Twitter

 

Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert