Associate Director, Biostatistics (RWD/CMC/Biomarker)

Location
San Francisco, CA, United States
Posted
Sep 06, 2018
Ref
3333-525-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Provide statistical consultation and analytical support to CMC, Non-Clinical, and Translational Science teams.

As the Associate Director, Biostatistics, you will play a leading role in establishing an influential statistics unit within the biostatistics department to provide statistical consultation and analytical support to the CMC, non-clinical, and translational science teams. Will oversee all statistical activities and will be responsible for providing clinical study(s) support to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Will provide strategic and expert statistical consultation on statistical issues throughout the drug development continuum including discovery, manufacturing, clinical development, and commercialization. Viewed as a key resource by senior individuals on strategic initiatives, and sought out for advice by other functions.

Provide statistical consultation and analytical support to CMC, Non-Clinical, and Translational Science teams. Partner with Medicinal Scientists to conduct extensive exploratory biomarker data analyses and data mining. Serve as a strategic partner to Research Scientists and provide support in optimizing the design, development and analysis of research projects. Conduct original research on relevant statistical topics focusing on current industry trends and coordinates learning/training opportunities within Statistics and for other functional areas. Provide statistical expertise on how to utilize real world evidence to help design more efficient clinical trials, support regulatory filings, or answer critical questions from the reimbursement agencies around the world. Promote, evaluate, and implement innovative clinical trial designs and efficient analysis methodologies when appropriate. Ability to identify the most critical aspects of a problem/issue and use competitive intelligence to influence clinical development strategies. Utilize appropriate internal and external resources to achieve short term and long term strategic functional goals. Identify and interact with external statistical experts for issues related to drug development. Provide input for planning and management of external budgets related to statistical deliverables. Participate/lead external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practices and its applicability.

Ph.D. in Biostatistics or closely related discipline with at least 6 years of relevant experience or an MS in Biostatistics or equivalent with at least 9 years of relevant experience. Excellent analytical and problem-solving skills with a keen understanding of statistical principles and concepts. Statistical expertise in CMC, biomarker, and discovery data analysis methodologies. Advanced knowledge of the pharmaceutical industry, overall drug development process with expertise in cross-functional interactions with the statistics function. Experience in integrating real world evidence into drug development, and expertise in big data and machine learning techniques is a plus. Strong statistical programming skills. Ability to work both independently and collaboratively within a cross-functional team. Strong oral and written communication skills, as well as, interpersonal and project/people management skills. Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries. Proven ability to directly supervise personnel, providing guidance, inspiration and motivation.

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.