We anticipate hiring for this role in mid-Q4. The preferred location for this role is in Boston, MA with an onsite requirement of Monday-Wednesday every week.
Your impact:The Senior Manager/Associate Director of Statistical Programming is responsible for providing clinical trial studies statistical programming leadership, strategic guidance and technical support of high-quality stats data outputs within Rapport's Bipolar Mania program. This role is reporting directly to the head of statistical programming in the Biometrics group.
Your day-to-day: - Support Statistical Programming (SP) activities across all stages of clinical development (Phase I-IV), from protocol development design to clinical study report (CSR), health agency submission and post-marketing activities.
- Review and understand study documents, including the Protocol, electronic case Report Forms (eCRFs), Statistical Analysis Plans (SAPs), Data Transfer Specification, CDISC Standard Data Tabulation Model (SDTM) and Analysis Dataset Model (ADaM) specification and CSR.
- Serve as the clinical trial SP lead by developing, validating, and documenting SAS programs for SDTM, ADaM, and TFL outputs supporting CSRs, DSUR/IB updates, publications, and ad hoc, ISS and ISE deliverables.
- Manage outsourcing strategy and oversee deliverables from CROs and external vendors.
- Ensure compliance with industry standards (CDISC, ICH, FDA/EMA guidance) and company SOPs.
- Provide programming oversight for regulatory submissions (e.g., NDA/BLA/MAA), including eCTD packages, define.xml, and reviewer guides (cSDRG and ADRG).
- Engage the development and implementation of programming standards, automation tools, and quality control processes.
- Collaborate with Biostatistics leadership to ensure integration of statistical and programming workflows.
- Collaborate with statistical programmers at all levels to foster a strong, supportive, and motivated programming team.
- Contribute to cross-functional initiatives to improve data quality, efficiency, and innovation in clinical development.
Must-Haves:- Master's or Bachelor's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
- 8-10 years of experience in statistical programming within the biotech/pharmaceutical/CRO industry
- Title and compensation commensurate with experience and education
- Expert-level proficiency in SAS (Base, Macro, STAT, GRAPH) and strong experience with CDISC standards (SDTM, ADaM) in clinical trials.
- Strong SP clinical trial study project management skills and ability to manage multiple priorities in a fast-paced environment.
- In-depth knowledge of clinical trial processes, GCP, regulatory requirements (FDA, EMA), and ICH guidelines.
- Experience managing and developing high-performing teams, both internal and external (CRO/vendor).
- Excellent interpersonal, communication, and leadership skills.
- Experience supporting regulatory submissions, such as NDA, BLA, or MAA filings, is preferred.
- Familiarity with R, Python, or other programming languages is a plus.
- Experience in Neurology or CSN highly desirable.
What makes Rapport special:- Every role has meaning. We're determined to discover a better way for patients, and you'll feel the passion from the start.
- We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
- Your perspective matters. Stick your neck out, share your ideas - we work as a team.
- We have FUN. We hire smart, dedicated, down-to-earth people that you'll enjoy spending time with.
- Leadership that CARES - about you, your growth + development.
- We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston - we make the most of our time together.
- Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
- You get to be YOU! Show up as you are and make every day count.
Your Compensation:We get it. Compensation is an important part of your offer. You shouldn't be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for the role to be $200,000 to $220,000 for the Associate Director level. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don't stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.
Hybrid Work Environment:We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.
