Job Description

RWE/HEOR STATISTICAL PROGRAMMERS to join Real world Research within Scientific Affairs, located in Titusville, NJ, or Raritan, NJ or work remotely in the United States of America.

The STATISTICAL PROGRAMMERS play a key role in support of real world research projects. They are responsible for ensuring efficiency, timeliness and quality of deliverables of statistical analysis.

KEY RESPONSIBILITIES:

AS AN EXPERIENCED STATISTICAL PROGRAMMER

-       Designs and develops programs in support of complex claims or EHR data analysis and reporting activities.  

-       Applies technical and analytical expertise to develop and implement solutions for use on claims or EHR projects leading to increased efficiency and quality.  

-       Uses SAS, SQL, or other programming skills to create analytical datasets from health care claims, electronic health record, surveys, and other data sources by following protocols and statistical analysis plans.

-       Constructs outcome measures and other analytical variables through data cleaning and data manipulation.

-       Generates descriptive tables, figures, etc. based on desired format using SAS and analytical reports.

-       May develop standard macros using SAS for frequently used programs/based on the team’s requirement; document and manage library of source codes and algorithms for internal use

-       May use macros and advanced techniques to combine data from different data sources and databases.

-       Collaborates effectively with other statistical programmers and Real World Researchers and possibly cross-functional team members and counterparts to achieve project goals.

-       Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.  

-       May contribute to departmental innovation and process improvement projects.

-       Ability to work independently on multiple projects with competing priorities and a strong commitment to meeting goals and deadlines

QUALIFICATIONS

EDUCATION:

Bachelor’s degree or higher and/or equivalent in quantitative sciences (mathematics, statistics, economics, etc.), data science/analytics, public health, or other relevant scientific field (or equivalent theoretical/ technical depth).

EXPERIENCE AND SKILLS:

-       Approximately 2+ years programming experience with increasing responsibility, preferably in a pharmaceutical, consulting, clinical or academic environment. 

-       Advanced knowledge of relevant statistical programming languages including SAS (required), SQL (required), other relevant programming languages (e.g. R, Python etc. preferred), and data structures.      

-       Required working experience and knowledge with claims, EHR, registries, survey data. 

-       Strong understanding and experience in resolving data issues with a logical, instinctive, and problem-solving mentality working with large, complex and incomplete data sources.

-       Demonstrated experience planning and coordinating programming activities.

-       Demonstrated detail-oriented problem solving, analytical reasoning and decision-making skills. 

-       Demonstrated experience working with cross functional stakeholder and teams.    

-       Basic project management skills. 

-       Demonstrated written and verbal communication skills in IT and business environments; ability to communicate to technical and non-technical audiences.

-       Knowledge of applying statistics and epidemiology on RWD is preferred.

-       Experience of creating customized analytic tools (e.g., SAS Macros) is preferred. 

-       Experience of populating complex tables and creating customized figures is preferred.

SR. BIOSTATISTICIAN, CONTRACT AND PERMANENT(CAN BE REMOTE)

• Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review. • Work with the clinical study team on study design, development and/or review of clinical study protocols. • Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed. • Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. • Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, ensure the quality of CRO deliverables. • May work with the Health Outcome team on the design/analysis/validation of projects. • May work on submission teams as a statistician and/or a programmer. QUALIFICATIONS NEEDED: • Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 3 years of experience in the pharmaceutical, CRO or biotech industry. • Strong SAS programming skills. • Oncology experience is highly preferred. • Good technical writing skills. • Good communication skills (verbal and written). • Strong teamwork ability/commitment and individual initiative. • Strong organizational skills with ability to effectively manage multiple projects. we need is an experienced statistician who can do SAS programming at the same time can clearly interprete statistical concept and results to non-statisticians and key medical opinion leaders.

SR. STATISTICAL PROGRAMMER(REMOTE),

This role is responsible for programming clinical trial analysis deliverables with quality and timeliness, with a hands-on and collaborative approach with other team members. This position requires high degree of independence, technical skills and ability to influence the team to get results without line management authority. MAJOR RESPONSIBILITIES: • Review a clinical study protocol with regard to statistical programming responsibilities • Review and provide input to a Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP) • Review and provide input to Case Report Forms (CRFs) and external data transfer agreements • Work cooperatively with and hold accountable clinical study team members including but not limited to the biostatistician, data manager, and medical writer • Work cooperatively with and oversee a contract programming provider • Assign tasks, set priorities, and provide technical help to clinical study programming teams • Develop and maintain SDTM and ADaM specifications • Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications • Understand and enforce compliance with programming standards and data standards in clinical study programming teams • Provide accurate programming time estimates and risk mitigation plans to management or a study team • Proactively inform management of the status of statistical programming deliverables and issues • Oversee on-time delivery from clinical study programming teams and meet timelines for multiple concurrent studies • Contribute to or initiate standards or process improvements REQUIRED SKILLS: • Excellent SAS programming skills; contribute programming to a global library of macros • Able to communicate clearly in oral or written form • Advanced knowledge of CDISC standards and applying standards to complicated data • Advanced knowledge of lab data processing and able to resolve issues • Working knowledge of medical terms, the data coding process, and coding dictionaries • Apply regulatory agency guidance in statistical programming responsibilities PREFERRED SKILLS: • Able to program in other languages (e.g. R or S-PLUS, VBA, or Perl) • Advanced knowledge of Unix commands; able to program shell scripts for complicated tasks • Advanced knowledge of inferential statistics REQUIREMENTS/QUALIFICATIONS: Education: Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. Experience: A minimum 5 years of SAS programming in clinical studies including leading a clinical study programming team

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