Title: Associate Director, Statistical Programming
Remote – US BASED
Salary + Bonus + Equity + Full Benefits package
Note: The position will not provide Sponsorship at this time
Reporting to the Statistical Programming Lead, the individual will be responsible for providing hands-on programming support and technical guidance on the project, including overseeing, developing, testing, maintaining, validating, and documenting SAS programs. As part of the programming team, this individual will also need to guide and validate the CRO programming deliverables and work collaboratively with internal and external teams in results reporting and regulatory submissions.
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
We work with a range of life sciences organizations across multiple industry disciplines, with one of our strongest portfolio’s in Statistical Programming – With US offices strategically located on the east coast (DC Metro) and west coast (San Diego) we connect rare life sciences talent with emerging companies nationwide.
- Lead statistical programming activities for development programs and studies, and ensure statistical programming deliverables are delivered by CROs within timelines and with high quality.
- Review CRO deliverables and perform acceptance checks and validation to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards for SDTM and ADaM.
- Perform hands-on SAS programming to generate TLFs to support ad hoc requests and decision making.
- Review data management related documents such as CRF Design Specification, data transfer agreements/specifications, data management plan and annotated CRF along with CRF Completion Guidelines; perform other tasks as needed, including UAT of clinical databases, and edit check specifications to support internal data management team.
- Manage and oversee CRO deliverables of SDTM specification, ADaM specification, Statistical Analysis Plan, and TFL Mock shells to provide statistical programming feedback.
- Oversee or perform the production, validation, and/or review of tables, listing and figures for clinical study reports and integrated summaries in support of regulatory submissions and publications.
- Oversee CRO deliverables of SDTM and ADaM define package along with Pinnacle 21 reports.
- Collaborate with internal and external functions to ensure project timelines and goals are met.
- Perform validation of CRO deliverables for integrated summary of Safety (ISS) and integrated summary of Efficacy (ISE) in support of NDA submission.
- Identify, develop, and maintain statistical programming standards, processes, and SOPs.
- Master’s degree in Statistics, Mathematics, or Computer Science or in a related field.
- Minimum of 10+ years Biotechnology/Pharmaceutical/CRO industry experience as a statistical programmer.
- NDA submission experience is a plus.
- Extensive knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
- CNS drug development experience is a plus.
- Ability to manage multiple projects in a fast-paced environment.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
- Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
- Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
- Experience working with CROs, vendors, and relationship management preferred.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.