Senior Manager/Associate Director, Statistical Programming

Rapport Therapeutics•Boston, MA

1d•$200,000 - $220,000•Hybrid

About The Position

The Senior Manager/AD of Statistical Programming is responsible for providing clinical trial studies stat programming leadership, strategic guidance and technical support of high-quality stats data outputs within Rapport’s clinical development programs. Reporting directly to the head of statistical programming in the Biometric groups. 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.

Requirements

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
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.

Nice To Haves

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.

Responsibilities

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.