Job Title: Associate Director, Statistical Programming
Job Duties:
- Lead design and development SAS programs and the programming specifications for producing and validating CDISC ADaM datasets to support the generation of tables, figures and listings for clinical study report(s), FDA submission(s), and medical congress abstracts/posters/presentations;
- Responsible for internal statistical programming deliveries across multiple clinical studies, as well as implementing process improvements and department initiatives;
- Identify areas within clinical development functions where statistical programming tools and applications can enhance processes;
- Perform quality control checks of advanced SAS code and output produced by other statistical programmers;
- Work closely with clinical operations, data management and statisticians to develop infrastructure for timely and quality reporting of clinical trials to support regulatory requirements, and product launch activities;
- Proactively identify issues and recommend solutions to optimize preparation, execution, reporting, and documentation of statistical programming activities;
- Provide project management and technical guidance to ensure operational and technical excellence;
- Liaise with vendors as needed to facilitate electronic data transfers and statistical programming support.
Requirements: Requirements include a Bachelor’s or equivalent in Regulatory Affairs, Statistics, Computer Science or related field plus nine years of work experience in the job offered or related fields of clinical data and statistical programming in pharmaceutical or biotech industries; or in the alternative, a Master’s degree or equivalent in Regulatory Affairs, Statistics, Computer Science or related field plus seven years of work experience in the job offered or related fields of clinical data and statistical programming in pharmaceutical or biotech industries.
Special Requirements:
If qualifying with bachelor’s degree, must have the following:
- 9 years of experience with SAS programing;
- 9 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS;
- 7 years of experience with CDISC SDTM and ADaM;
- 7 years of experience with electronic FDA submission; and
- 9 years of experience working in a clinical trial setting.
If qualifying with Master’s degree, must have the following:
- 7 years of experience with SAS programing;
- 7 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS;
- 5 years of experience with CDISC SDTM and ADaM;
- 5 years of experience with electronic FDA submission; and
- 7 years of experience working in a clinical trial setting.
Work Location: Needham, MA
May work remotely from anywhere in U.S.
Multiple positions available. Applicants must have unrestricted authorization to work in the United States.
Salary: $165,000.00 - $190,000.00/year. 40 hours/wk full-time.
If interested and qualified for this position, please apply below.
Skills Required
- Bachelor's degree in Regulatory Affairs, Statistics, Computer Science or related field plus 9 years of clinical data/statistical programming experience in pharmaceutical or biotech industries
- Master's degree in Regulatory Affairs, Statistics, Computer Science or related field plus 7 years of clinical data/statistical programming experience in pharmaceutical or biotech industries
- 9 years of experience with SAS programming (if qualifying with bachelor's)
- 7 years of experience with SAS programming (if qualifying with master's)
- 9 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS (if qualifying with bachelor's)
- 7 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS (if qualifying with master's)
- 7 years of experience with CDISC SDTM and ADaM (if qualifying with bachelor's)
- 5 years of experience with CDISC SDTM and ADaM (if qualifying with master's)
- 7 years of experience with electronic FDA submission (if qualifying with bachelor's)
- 5 years of experience with electronic FDA submission (if qualifying with master's)
- 9 years of experience working in a clinical trial setting (if qualifying with bachelor's)
- 7 years of experience working in a clinical trial setting (if qualifying with master's)
- Ability to work from Needham, MA or remotely from anywhere in the U.S.
- Unrestricted authorization to work in the United States
What We Do
Verastem Oncology (Nasdaq: VSTM) (Verastem, Inc.) is a biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition and KRAS G12D inhibition. Pursuing unexplored pathways demands that we’re purposeful in everything we do. And it’s an endeavor that’s only possible with an experienced team of employees and partners dedicated to a singular purpose: changing and improving the way cancer is treated by delivering novel therapies that address areas of high unmet need in RAS/MAPK pathway-driven cancers. At Verastem Oncology, it takes our diversity of backgrounds, expertise, perspectives, and skills to find the answers that patients need, but don’t have—yet. To join our team or for more information, please visit www.verastem.com. X/Twitter: @VerastemOncolog
