Associate Director, Statistical Programming

SERVIER MONDE•Boston, MA

2d•$165,000 - $200,000•Hybrid

About The Position

The Associate Director, Statistical Programming leads statistical programming activities for multiple studies, an asset or an indication by performing hands-on programming or oversight of outsourced deliverables. This individual will ensure that the statistical programming processes and deliverables are aligned with regulatory requirements and internal procedures. The role will interact closely with the study statisticians and study team regarding statistical programming aspects.

Requirements

Masters in Statistics, Engineering or relevant field required
minimum of 8 years of experience in statistical programming or biostatistics in the Pharmaceutical/Biotechnology industry in clinical development desirable
Experience with statistical programming in Oncology desirable
Proficient in SAS
Good knowledge of CDISC ADaM and SDTM
Strong knowledge of relevant regulatory and data submission guidelines
Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions
Self-directed, technically strong, expert regarding statistical programming processes, management of statistical programmers at study level
Strong study management skills
Good negotiation and issue resolution skills
Ability to organize team work and prioritize and balance concurrent tasks and responsibilities.
Excellent time management skills
Ability to educate internal and external interfaces (CROs and contractors) on the statistical programming processes, and the underlying regulatory requirements

Responsibilities

Manage statistical programming deliverables on one or more assets or indications by managing study leads and oversee study activities and vendor oversight.
Oversee development and quality control or oversight plan of analysis datasets and outputs for individual study as well as integrated analyses.
Ensure study leads deliver high quality, traceability, reproducibility of study outputs and timeliness of statistical programming deliverables to meet expectations and regulatory requirements.
Mentor statistical programmers with regards to programming activities and project management.
Independently implement routine and non-standard analysis algorithms for assigned projects or studies.
Collaborate with statisticians, local and CRO programmers to define and implement analysis requirements and perform sponsor oversight regarding data and analysis.
Ensure an efficient collaboration with all members of the clinical study team.
Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance: Clinical study reporting, e.g. ICH E3; Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11; Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards.
Ensure that the datasets (SDTMs and ADaMs) are CDISC compliant.
Support on the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.
Work with the portfolio programming lead to create forecasts for different studies and resource requirements.
Participate in working groups (either inter department or cross functional).
Participate in the preparation of audit/inspection and could interact with auditors/inspectors.
Contribute to the establishment and maintenance of common formats and templates for key Programming documentation (e.g., standard CRF pages, Tables, Figures and Listings).
Plan and track project activities, timelines across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation.