Senior Director, Statistical Programming

Location
South San Francisco, CA, United States
Posted
Jul 19, 2019
Ref
167
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
About Assembly: Assembly Biosciences (NASDAQ: ASMB) is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly's fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL ® technology. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add to our dynamic team great people who are driven to transform the lives of patients.

We believe our Microbiome platform represents a best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in mildly to moderately active ulcerative colitis (UC), is currently in a phase 1b clinical trial. This program is part of a broader collaboration we established with Allergan in 2017 for gastrointestinal programs such as UC, Crohn's disease and Irritable Bowel Syndromes with potential total development and commercial milestones of up to $2.8 billion. Our internal pipeline comprises first in class or best in class live microbial biotherapeutic approaches in areas such as oncology, immune mediated and metabolic disorders, and other areas of high medical need.

Assembly is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and offices in China. Assembly has a strong balance sheet having raised approximately $166 million in July 2018. We are positioned well to build the next phase of the Company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.

Summary:

The Senior Director, Statistical Programming will be responsible for all statistical programming activities. This person will support clinical trials, including technical and project leadership overseeing the quality and timely delivery of all statistical programming deliverables for studies or for submissions.

This person will ensure the team develops, maintains, validates and runs quality SAS programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. (S)he will promote strong collaboration with Biostatistics to support analyses for regulatory, medical affairs, and market access needs, as well as strong collaborative relationships with Data Management, Safety, and Clinical Pharmacology. This position may also include people management responsibilities for statistical programmers.

Specific responsibilities include, but are not limited to:

· Lead SAS Programming for all compounds and key NDA related activities

· Planning and track the statistical programming activities including designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting safety and efficacy analyses

· Plan and manage the internal and external SAS programming resources (providing guidance, direction, motivation, and professional development)

· Manage CROs to meet timelines and expectation of quality

· Work collaboratively with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines

· Program for SDTM data mapping and creation of ADaM datasets and the corresponding specifications according to CDISC standards

· Program TLFs for implementation of the statistical analysis plans and for AdHoc analysis in clinical trial of all phases

· Perform programming QC on TLFs

· Track clinical trial milestones and works with vendors for statistical reporting deliverables.

· Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation

· Understand and performs in accordance with regulatory standards, and drug development principles

· Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package

· Plan, develop, test, and document SAS macros for programming efficiency

· Function as a lead for statistical programming process improvement, CDISC SDTM/ADaM data standardization

Qualifications include:

· BS/MS in Statistics, Math or Scientific Discipline; Ph.D preferred

· Minimum of 12 years progressive Pharmaceutical/Biotech programming experience including macro/tools development experience

· Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development

· Ability to define and implement CDISC compliant SDTM and ADaM data and specifications

· Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions

· Demonstrated management experience

· Oncology experience is a plus

· FDA submission experience is highly desirable

· Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat, Software Development Life Cycle and CDISC standards (SDTM & ADaM)

· Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus

· Ability to use professional concepts to achieve objectives in creative and effective ways.

· Ability to thrive in a fast-paced environment managing multiple projects

· Some travel may be required for this position

AAP/EEO Statement
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.