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Stat Programmer Jobs in Massachusetts (NOW HIRING)

Parexel

Statistical Programmer II

Newton, MA · On-site

$115K - $132K/yr

Statistical Programmer II Duties: Parexel International LLC seeks a Statistical Programmer II ... Stat, Macro, EG, Studio, Graph, ODS, and Report; (7) Creating define.xml files and reviewer ...

Parexel

Statistical Programmer II

Newton, MA · On-site +1

$115K - $132K/yr

Statistical Programmer II Duties: Parexel International LLC seeks a Statistical Programmer II ... Stat, Macro, EG, Studio, Graph, ODS, and Report; (7) Creating define.xml files and reviewer ...

Parexel

Statistical Programmer II

Newton, MA · On-site

$115K - $132K/yr

Statistical Programmer II Duties: Parexel International LLC seeks a Statistical Programmer II ... Stat, Macro, EG, Studio, Graph, ODS, and Report; (7) Creating define.xml files and reviewer ...

Servier

Sr. Manager, Statistical Programming

Boston, MA · On-site

$151K - $172K/yr

Ensure the statistical programming processes and deliverables are aligned with regulatory requirements and internal procedures. Interact with the study statisticians and study team regarding ...

Biogen

Sr. Analyst, Statistical Programming

Cambridge, MA · On-site

$100K - $130K/yr

Bachelor's degree required. * 5+ years relevant work experience within an organization with a focus on data management and analysis. * 5+ years SAS Base programming with 5+ years using SAS STAT ...

Vrtx

Principal Statistical Programmer

Boston, MA · Remote

$149K - $223K/yr

The Principal Statistical Programmer works with management to delegate tasks appropriately, track ... language, BASE SAS, SAS/STAT and SAS/GRAPH * Intermediate knowledge of CDISC Standards

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Associate Director, Statistical Programmer

Associate Director, Statistical Programmer

Beam Therapeutics

Cambridge, MA • On-site

Other

Posted 23 days ago

Job description

Position Overview:

Beam is looking for a Senior Manager/Associate Director of statistical programming to join our growing Statistical Programming team in the Biometrics department. This individual will be responsible for developing and maintaining statistical programming functions within a therapeutic area to support various clinical studies and submissions to ensure successful execution for Beam's clinical programs. In this role, you will work with the head of statistical programming and the head of biometrics to develop statistical programming strategies, SAS programming infrastructure as well as department standards, applications and processes. You will manage CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.

Responsibilities:

  • Lead and manage statistical programming activities on clinical studies and oversee CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions.
  • Review and validate SDTM, ADaM analysis datasets and TFLs created by CROs.
  • Work collaboratively and communicate effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions.
  • Manage creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources.
  • Manage the activities of data summary, statistical analysis, patient profile, safety and efficacy tables, listings and figures using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R.
  • Oversee and manage the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures.
  • Partner with Statisticians and other members of the clinical study team, perform ad hoc analysis.
  • Review SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents by CROs and provide expert feedback from functional perspective.
  • Assist the Head of Statistical Programming in reviewing bid proposals, monitoring and tracking budgets for outsourced activities.
  • Assist the Head of Statistical Programming to develop and implement programming processes, programming standards and SOPs.
  • Develop SAS programming infrastructure and programming processes to improve data deliverables and ad hoc analyses quality and efficiency.
  • Build and mentor a team of programmers as needed to support Beam clinical trials and drug development pipelines.

Qualifications:

  • MS or higher degree in Statistics, Mathematics, or related scientific Discipline.
  • At least 12 years Pharmaceutical/Biotech programming experience.
  • Advanced SAS programming skills and strong Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
  • Experience and in-depth knowledge in CDISC including STDM, ADaM and controlled terminologies.
  • NDA or BLA submission experience is required.
  • Excellent organizational skills and ability to prioritize tasks.
  • Excellent communication and interpersonal skills.
  • Experience managing CROs and other data vendors.
  • Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance.
  • Experience with R-Shiny or Python is a plus.

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