Director, Statistical Programming - Brisbane, CA | Biospace
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Director, Statistical Programming

Aimmune Therapeutics

Location:
Brisbane, CA
Posted Date:
6/13/2017
Position Type:
Full time
Job Code:
17-07-CD-N
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Programmer, Statistics,

Job Description


In this fast-growing and fast-paced organization, your expertise is needed to provide leadership for all statistical programming activities related to regulatory submissions.

Key Responsibilities:

•   Implement a statistical programming environment
•   Identify programming tools that improve efficiency and quality
•   Lead the development of programming processes supporting global submission
•   Partner with vendors on all programming deliverables for global submission
•   Collaborate with data management, clinical development, and medical affairs to identify programming needs and manage the workflow
•   Manage programming timelines and ensure appropriate resource allocation
•   Provide oversight of all programming activities, including in house validation of vendor output and ISS and ISE activities
•   Recruit programming team members
•   Manage internal programming team including staff development and career growth

Requirements

•   BS, preferably in Mathematics, statistics, computer sciences or other related field
•   8+ years of clinical trials experience in pharmaceutical or biopharmaceutical setting
•   Proven experience leading statistical programming activities including eCTD for at least one FDA/EMA submission
•   Expertise in CDISC activities and regulatory submission preparation
•   Experience in managing external vendors including programming and validation plans for deliverables including QC of outputs
Special Skills:
•   Thorough knowledge of the drug development and regulatory submission cycle
•   Excellent project management skills
•   Excellent communication skills
•   Able to work in a fast pace and agile environment
•   In-depth and current knowledge of regulatory requirements and guidance
•   Excellent SAS and CDISC skills
•   Proficiency in MS Word, Excel, PowerPoint, and Project.

About Aimmune Therapeutics, Inc.

Aimmune Therapeutics is a clinical-stage biopharmaceutical company located in Brisbane, California, in the biotechnology hub south of San Francisco. The company is developing desensitization treatments for food allergies and plans to initiate an international Phase 3 trial for its lead product, for the treatment of peanut allergy, in early 2016. For more information, please visit www.aimmune.com.

Aimmune Therapeutics offers a competitive compensation and benefits package.

Aimmune Therapeutics is an Equal Opportunity Employer.

Principals only; no recruiters please.