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Senior Manager Statistical Programming Jobs in Texas

Collaborate with Statistics, Data Management, Clinical, and vendor teams to clarify requirements and resolve data or programming issues. * Develop, validate, and maintain SAS programs in accordance ...

Statistical Programmer II

Dallas, TX ยท On-site

$90K - $100K/yr

Collaborate with Statistics, Data Management, Clinical, and vendor teams to clarify requirements and resolve data or programming issues. * Develop, validate, and maintain SAS programs in accordance ...

Statistical Programmer II

Austin, TX ยท On-site

$90K - $100K/yr

Collaborate with Statistics, Data Management, Clinical, and vendor teams to clarify requirements and resolve data or programming issues. * Develop, validate, and maintain SAS programs in accordance ...

In this vital role you will provide both strategic oversight and hands-on statistical programming ... The manager will serve as a technical programming expert who can rapidly respond to internal and ...

Mid - Senior Level This is what you will do.. You will be using quantitative methods to assess the ... Who is proficient in Applied Statistics/Econometrics, Statistical Programming, Database Marketing ...

Mid - Senior Level This is what you will do.. You will be using quantitative methods to assess the ... Who is proficient in Applied Statistics/Econometrics, Statistical Programming, Database Marketing ...

Mid - Senior Level This is what you will do.. You will be using quantitative methods to assess the ... Who is proficient in Applied Statistics/Econometrics, Statistical Programming, Database Marketing ...

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Senior Manager Statistical Programming information

What are Senior Manager Statistical Programming?

A Senior Manager Statistical Programming is a leadership role in the field of clinical research and biostatistics, typically within the pharmaceutical, biotechnology, or contract research organization (CRO) industries. This professional oversees teams of statistical programmers responsible for analyzing clinical trial data, ensuring data accuracy, and delivering high-quality statistical outputs for regulatory submissions. The role involves project management, resource allocation, mentoring staff, and collaborating with cross-functional teams to ensure compliance with regulatory standards and timelines.

What is the difference between Senior Manager Statistical Programming vs Statistical Programmer?

AspectSenior Manager Statistical ProgrammingStatistical Programmer
CredentialsBachelor's/Master's in Biostatistics, Computer Science, or related field; often with management experienceBachelor's or Master's in Biostatistics, Statistics, or related field
Work EnvironmentLeads teams, manages projects, collaborates with cross-functional teamsPerforms data analysis, programming, and validation tasks under supervision
Employer & Industry UsagePharmaceutical, biotech companies, CROs, clinical researchPharmaceutical, biotech, clinical research organizations

The main difference is that Senior Manager Statistical Programming oversees teams and manages projects, while Statistical Programmers focus on executing data analysis and programming tasks. The senior role involves leadership responsibilities, whereas the programmer role is more technical and task-oriented.

What are the key skills and qualifications needed to thrive as a Senior Manager Statistical Programming, and why are they important?

To thrive as a Senior Manager Statistical Programming, you need expertise in biostatistics, programming languages like SAS or R, and experience with clinical trial data, typically supported by an advanced degree in a quantitative field. Familiarity with regulatory requirements (e.g., CDISC standards), clinical data management systems, and project management tools is essential. Strong leadership, communication, and problem-solving skills help you lead teams and liaise with cross-functional stakeholders. These skills ensure accurate, compliant data analyses and effective team management for successful clinical trial outcomes.

How does a Senior Manager Statistical Programming typically collaborate with cross-functional teams in clinical research projects?

A Senior Manager Statistical Programming plays a pivotal role in coordinating with biostatisticians, clinical data managers, and medical writers to ensure seamless data flow and analysis throughout clinical trials. They oversee programming teams to deliver statistical outputs, such as tables, listings, and figures, while maintaining compliance with regulatory standards. Regular meetings and clear communication are essential, as the Senior Manager must interpret project requirements and translate them into actionable programming tasks, ensuring timelines and quality standards are met. This collaborative environment fosters continuous learning and problem-solving, as cross-functional input is vital for addressing complex data challenges.
What are the most commonly searched types of Senior Statistical Programming jobs in Texas? The most popular types of Senior Statistical Programming jobs in Texas are:
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Senior Statistical Programmer

Senior Statistical Programmer

Katalyst HealthCares & Life Sciences

Austin, TX โ€ข On-site

Other

Posted 23 days ago


Job description

Statistical Programmer

Responsibilities:

Ensure departmental or functional training plans in place and appropriate

Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget

Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications

Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications

Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports)

Maintain complete and auditable documentation of all programming activities

Manage datasets and output across SAS programs, studies, and indications to ensure consistency

Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests

Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures

Develop and/or maintain departmental procedures and standards

Review CRFs, edit check specifications, and table, figure, and listing mock-ups

Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer's guide documents

Assist in validation of SAS per 21 CFR Part 11

Train and mentor new members and programmers; supervise contract programmers, as needed

Requirements:

Bachelor's degree in Statistics, Mathematics, Computer Science or a related field required

Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer

Prior experience overseeing statistical programming contractors required

Compound oversight experience highly preferred

Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS

Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred

Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines

eCTD NDA submission experience is a must.


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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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