Principal Statistical Programmer

Principal Statistical Programmer

at Precision Medicine Group (View all jobs)

Remote, United States

Position Summary:

Support, lead, and provide oversight to SAS programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet project needs; Provide technical expertise to the development of programming standards and procedures. May serve as the project manager for assigned projects.

Essential functions of the job include but are not limited to:

Review CRFs, edit check specifications and table mock-ups

Create specifications for SDTM and ADaM datasets

Oversee generation of blankcrf.pdf aCRFs and define.xml files

Generate SDTM and ADaM datasets, tables, listings, and figures to support the analysis of clinical trials data

Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests

Perform quality control (including documentation) for SAS programs and other study documents (e.g., presentations and reports)

Review, maintain and approve study documents per standard procedures

Interact with clients and lead statistical programming efforts for the project team; serve as the primary project team representative, delegating work as appropriate

Prepare reports (i.e. patient profiles, SAP related outputs, interim analysis) for Data Monitoring Committees (DMCs)

Assist with training of new hires; provide ongoing training and mentorship for statistical programmers

Participate Lead or oversee in the development and maintenance of departmental procedures/standards

Program, test and document global utility programs and tools in accordance with standards and validation procedures

Provide technical oversight and leadership when needed for analysis and reporting; may serve as the project manager for assigned projects

Lead cross-functional development activities

Other duties as assigned

Qualifications:

Minimum Required :

Bachelor's degree in Statistics, Mathematics, Computer Science, or in a related field; 8+ years SAS programming experience (preferably in Biotech / clinical trials / related industry)

Other Required:

Knowledge of industry standards, such as ICH guidelines, CDISC data structures, 21 CFR Part 11 and FDA guidelines

Broad programming experience supporting clinical trials in the Biotechnology / Pharmaceutical / CRO Industry

Preferred:

SAS Certified Advanced Programmer for SAS 9 or equivalent proficiency

Broad experience with Oncology and Rare Diseases

Broad experience with ISS/ISE programming and submissions

Skills:

Excellent organizational skills, time management, and the ability to coordinate workload to meet established deadlines

Excellent communication and interpersonal skills to effectively interface with others (both internally and externally to foster client relationships)

Excellent problem solving skills

Ability to program/QC more complex analysis datasets and outputs (i.e. tables, ADaMs, efficacy related outputs, figures) in an efficient and readable manner

Proficient in SAS macro programming

Advanced computer skills

Demonstrated proficiency in interpreting statistical analysis plans

Competencies:

Sound judgment/decision making

Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients

Service oriented, accountable and flexible

Keen attention to detail in reviewing outputs for project deliverables

Ability to fulfill a variety of data-related roles while building company strength and experience in data activities

Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$141,200 - $211,800 USD

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