Oversees managing statistical programming projects and creating strategic plans related to clinical trials and medical affairs publications.
Leads the team in developing, maintaining, validating and running SAS programs that analyze and report clinical trial data.
Responsible for the structure of the statistical programming function and representing the function in cross-functional activities.
Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
Works closely with Biostatistics to implement statistical analyses of clinical trial data and develops ADaM specifications and datasets.
Manages internal and vendor statistical programming support; Maintains collaboration with preferred vendors.
Writes SAS programs that produce or validate tables, listings, figures, and analysis datasets, in support of clinical studies.
Performs, plans, and coordinates project work to ensure timely, quality delivery across multiple projects.

Requirements

PhD with 8+ years of experience or MS with 11+ years of experience in statistics or biostatistics or related disciplines with clinical trials, pharmaceutical/biotech industry, or healthcare experience.
Experience in supporting oncology phase II/III clinical studies.
Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA).
In-depth knowledge of CDISC standards.
Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, etc.
Excellent written and verbal communication skills.
Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable.
Strong computer and database skills.
Attention to detail, accuracy and confidentiality.
Clear and concise oral and written communication skills.
Excellent organizational skills.
Critical thinking, problem solving, ability to work independently. Must be able to effectively multi-task and manage time-sensitive and highly confidential documents. Communicate effectively and articulate complex ideas in an easily understandable way.
Prioritize conflicting demands. Work in a fast-paced, demanding and collaborative environment.

Benefits

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
Total compensation package may also include bonus, stock, benefits and/or other applicable variable compensation.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

SASREASTstatistical programmingADaM specificationsstatistical analysesexperimental designclinical trial data analysisregulatory submissionsCDISC standards

Soft skills

communication skillsorganizational skillsattention to detailcritical thinkingproblem solvingtime managementability to multi-taskindependencecollaborationarticulation of complex ideas

Certifications

PhDMS