Director, Statistical Programming

eClinical Solutions•Mansfield, MA

9h•$148,000 - $185,000

About The Position

The Director Statistical Programming provides input regarding planning, management, and logistics for statistical programming services. The Director Statistical Programming assists in developing the strategic vision for all statistical programming activities. The Director Statistical Programming will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. The Director Statistical Programming will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. The Director Statistical Programming will work as needed assuring that all client work has met or exceeded client expectations.

Requirements

Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field and/or equivalent work experience preferred
10+ years’ experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
5+ years in a leadership role managing teams, managers, or large-scale programming operations preferred
Excellent knowledge of English
Strong experience with clinical study design development, analysis, and sample size determination
Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule
Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses
Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures
Ability and experience of delegating tasks and leading projects. Experience of working on multiple clinical protocols at the same time
Ability to balance conflicting priorities
Excellent verbal and written communication skills
Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Excellent team player
Experience of statistical procedures and latest developments and trends in statistical analysis methodologies. Knowledge of working in different therapeutic areas and related indications
Strong knowledge of statistical programming and ability to use various software systems like SAS, SPSS, and S-Plus
Knowledge and ability to use various tools like J-Review, and Spotfire for effective data queries and analysis
Strong experience in various SAS software modules including SAS/STAT, and SAS/Graph
Thorough understanding of developing macros and SAS system
Thorough knowledge of design of experiments and statistical modeling. Experience of developing statistical designs for phase-I, phase-II, and phase-III clinical protocols
Experience of pooled data analysis and in designing specifications for integrating data from multiple trials
Thorough knowledge of analysis of various standard and non-standard safety domains. Knowledge of PK data modeling is a plus
Strong experience in efficacy reporting with regards to development of analysis sets and missing values
Proficiency in Microsoft Office Applications

Nice To Haves

SAS® certification is preferred
Ability to do statistical computing using R is a plus
Knowledge of Analysis dataset model for development of analysis and programming specifications is a plus. Ability to develop ADAM models based on trial data

Responsibilities

Provide input regarding planning, management, and logistics for statistical programming services
Assist in developing the strategic vision of the department which can be integrated into the overall corporate vision
Support the development of policies, procedures, and standards
Participate in resource management and allocation activities
Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required
Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications. If required, validate the statistical models used for programming
Act as a study Lead - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time
Develop, review, and finalize the statistical analysis plan
Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis
Develop randomization schedule, specifications, and guidelines
Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting
Wherever applicable, develop, validate, and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables
Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately
Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses
Collaborate with team members for regulatory reviews, representations, and supporting data analyses including the study or compound level exploratory analyses, ad-hoc analyses, and post- hoc analyses
Develop SAS programs to generate analysis datasets, and trial specific reporting including but not limited to tables, listings, graphs, queries, and patient profile reports
Champion the evolution of statistical programming through automation and advanced analytics using elluminate®
Lead internal initiatives focused on standards governance, coding conventions, validation frameworks, and reusable assets
Evaluate emerging technologies (R, Python, automation tools, AI-driven methods) to expand capabilities
Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures
Other duties as assigned