- Mentor and train junior levels of programming personnel within the Statistical Programming group
- Establish and implement programming standards and ensure compliance to Standard Operating Procedures (SOPs), guidelines and working instructions
- Remain informed of new developments in programming that are relevant to the industry and develop tools in SAS for data analysis and reporting that comply with regulatory requirements
- Develop SAS programs to produce statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP)
- Develop SAS programs to produce integrated analyses and tables for the summary sections of New Drug Applications (NDAs) including ISS and ISE
- Develop specifications (metadata files) and create SAS programs for the mapping of raw datasets to CDISC SDTM standards. Create files from metadata files and using Adobe Acrobat
- Develop SAS programs to produce analysis datasets in CDISC ADaM or other formats specified by the sponsor
- Design and implement quality control (QC) programs to ensure the quality and integrity of statistical programs which are used to generate datasets including CDISC SDTM and ADaM datasets
- Perform validation programming to ensure accuracy of TFLs and compliance with SAP and FDA regulatory requirements. Perform QC on program code and outputs produced by other team members
- Participate in the development of a library of SAS macros for use across multiple projects and in training biostatisticians and other programmers in their implementation
- Assist the Data Management Department by writing and testing edit check programs to check the data for syntax errors, logical inconsistencies, and protocol violations, and generate data listings to facilitate data review performed by the clinical data managers
- Provide input to the study team in the design of annotated case report forms in conjunction with the clinical data managers
- Maintain and modify code written by others
- Follow good programming practices, including writing code that is understandable, commented, and easy to modify
- Convert data received in other formats to SAS datasets
- Perform other duties as assigned
- Bachelor's degree required
- Bachelor's degree in Computer Science, Mathematics, Statistics, Life Sciences or a related field preferred
- Minimum of 8 years of experience using SAS in analyses of clinical trials data
- Must have worked within and be proficient with industry standards and clinical trial terminology and methodologies
- Experience with SAS for Windows, including BASE SAS (macros, ODS, SQL), SAS/ACCESS, SAS/STAT, SAS/GRAPH
- Skilled at writing complex SAS programs designed to analyze and report clinical trial data and transforming data to CDISC SDTM and ADaM formats
- Basic knowledge of FDA/ICH guidelines
- Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems
- Proficient in written communication and ability to communicate effectively to other programmers and non-technical colleagues
- Able to prioritize time effectively based on work demands and work independently
- Able to give effective presentations to small groups such as in Statistical Programming meetings
- Knowledge of other programming languages and database management software packages is a plus
-
Senior Statistical Programmer
5 days ago
Sarepta Therapeutics Cambridge, United StatesServes as a stat programming expert or point of contact for assigned clinical studies under close/limited supervision of the stat programming project lead · Primary Responsibilities Include: · • Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and ...
-
Senior Statistical Programmer
4 days ago
Prometrika Cambridge, United StatesPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the peop ...
-
Principal Statistical Programmer
1 week ago
Prometrika Cambridge, United StatesPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the peop ...
-
Principal Statistical Programmer
1 day ago
Prometrika LLC Cambridge, United StatesJob Description · Job DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our wor ...
-
Senior Statistical Programmer
3 days ago
Cytel - USA & APAC Waltham, United StatesSr. Statistical Programmer (FSP) · Join Cytel's enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. The Sr. Statistical Programmer provides Statistical Programming technical support to team members ...
-
Principal Statistical Programmer
2 weeks ago
Cytel - USA & APAC Waltham, United StatesCytel, Inc. (Cambridge, MA) is seeking Principal Statistical Programmers (multiple positions) to work directly with the stakeholders to lead statistical programming projects and to ensure the statistical programming systems, processes and deliverables are aligned with the relevan ...
-
Senior Statistical Programmer
3 weeks ago
Cytel - USA & APAC Waltham, United States Full timeCytel, Inc. (Cambridge, MA) is seeking Senior Statistical Programmers (multiple positions) to work directly with stakeholders to lead and contribute to statistical programming projects and to ensure the statistical programming systems, processes and deliverables are aligned with ...
-
Manager, Statistical Programmer
1 week ago
Takeda Lexington, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Noticeand Terms of Use. I further attest that all information I submi ...
-
Principal Statistical Programmer
1 week ago
Katalyst Healthcares and Life Sciences Hanscom Air Force Base, United StatesResponsibilities: Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. · Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables. · Create statistical analysis out ...
-
Principal Statistical Programmer
8 hours ago
Connect Life Sciences Bridgewater, United StatesActs as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets. · As ...
-
Principal Statistical Programmer
2 weeks ago
Katalyst HealthCares & Life Sciences Bridgewater, United StatesResponsibilities: Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements. Perform hands on prim ...
-
Remote Principal Statistical Programmer
1 week ago
Global Channel Management Framingham, United StatesJob Description: · Remote Principal Statistical Programmer needs 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience. · Remote Principal Statistical Programmer requires: · Minimum 10 years Pharmaceutical/Biotech programming experie ...
-
Clinical SAS Programmer
1 day ago
Katalyst Healthcares & Life Sciences Cambridge, United States**Responsibilities**: · - The SAS Programmer is responsible for developing and executing biostatistical (SAS) and data management related programs, processing data from various sources to support clinical and pharmaceutical projects and will include defining populations, creating ...
-
AbbVie Boston, United States**Company Description** · The Manager of Statistical Programming is a strategic role which guides a team of Statistical Programmers in the research and development of new pharmaceutical products. This role is directly responsible for leading the statistical programming activities ...
-
Community Care Cooperative Boston, United States**Title**:Programmer Analyst, Fenway Institute Applications · **Reports to**: Director, Fenway Health Data Analytics · **Classification**: Individual Contributor · **Location**:Hybrid · **Job description revision number and date**: V.20; · **Organization Summary**: · Community C ...
-
Registrar, School of Theology
1 day ago
Boston University Boston, United StatesOversee a broad range of student academic services including registration functions (such as maintenance of student academic records, course scheduling, production of the academic bulletin, graduation, and registration aspects of advising and orientation) and financial aid functi ...
-
Senior SAS Programmer
6 days ago
IntePros Cambridge, United StatesRESPONSIBILITIES: · Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms. · Offer technical support and expert advice to internal and external sponsors. · Lead and influence ongoing clinical studies by supporting statistic ...
-
Clinical SAS Programmer
1 week ago
Katalyst Healthcares and Life Sciences Cambridge, United StatesResponsibilities: Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. · Conduct hands-on validation/QC of CRO deliverables to ensure hig ...
-
Senior Manager, Statistical Programming
6 days ago
Bicycle Therapeutics Cambridge, United StatesBicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists ...
-
Senior Manager, Statistical Programming
6 days ago
Bicycle Therapeutics Limited Cambridge, United StatesCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-target ...
Senior Statistical Programmer - Cambridge, United States - Prometrika LLC
Description
Job Description
Job DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.
The Sr. Statistical Programmer will create specifications and develop SAS programs for data tabulation, analysis and reporting that comply with regulatory requirements (CDISC SDTM and ADaM), SOPs/ SAP, and lead junior level programming personnel. This is an exempt position and reports directly into the Director, Statistical Programming.
RESPONSIBILITIES
EDUCATION
EXPERIENCE
SKILLS
Physical Requirements
Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.