Associate Director, Biostatistics

Location
San Francisco, CA, United States
Posted
May 04, 2018
Ref
3273-525-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

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.

Responsibilities:

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 bio-statistical 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.

Requirements:

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.