- ct as an integral member of the project team. Attending project team meetings, working with Biometrics vendor, biostatistician, data manager, medical lead, clinical trial manager and other functions to meet project deliverables and timelines.
- Manage all programming activities within a study, including timeline and resource planning.
- Lead or support the programming team and Biometrics vendors to produce SDTM/ADaM dataset, TFLs and supporting submission documents.
- Program statistical analyses using SASO supporting ad-hoc analysis, integrated analysis such as ISS and Client. Code SAS utility macros: implement test plans to support SAS macro development.
- Understands and follows FDA regulations which affect the reporting of clinical trial data.
- Participates in cross functional initiatives representing Statistical Programming.
- Provide review and input to study documents and processes (such as Statistical Analysis Plans, eCRFs, SOPs, etc.).
- Understand and follow FDA regulations which affect the reporting of clinical trial data.
- Develop and/or contribute to data collection, analysis and reporting standards content and processes.
- Mentor junior level staff in programming practices.
- Bachelor's or higher degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
- t least five (with Bachelor's degree) or four (with master's degree) years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
- Excellent technical skills; familiarity with coding dictionaries.
- Experience and in-depth knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies.
- bility to communicate technical concepts clearly and concisely to non-technical colleagues.
- Strong organizational skills, attention to detail, and self-motivation.
- Vendor management experience.
- Experience in creating all components of a submission package.
- Oncology Therapeutic area experience.
- RTOR experience.
-
Clinical SAS Programmer
17 hours 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 ...
-
Clinical SAS Programmer
5 days ago
LLX Solutions Waltham, United States Full timeResponsibilities:Conduct clinical programming to support clinical data management, data cleaning, and data review, as well as external data reconciliation in accordance with standards (CDISC, MedDRA, WHO-DD, FDA)/SOPs or study specific guidelines · Work with Data Manager to gene ...
-
Senior SAS Programmer
5 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 ...
-
Clinical SAS Programmer
3 days ago
Katalyst Healthcares and Life Sciences Bridgewater, United StatesResponsibilities: Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users. · Use your expertise in data standards a ...
-
Sas Programmer with clinical
4 days ago
Elajika Boston, United States Full time, contractExperience; 2+Duration; 6MonthsRoles and Responsibilities Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications datasets SDRG Annotated CRF) for Client studies Serve as Study SDTM Programming lead for all regulatory submissions Expertise in ...
-
Clinical SAS Programmer
3 days ago
Katalyst Healthcares and Life Sciences Danvers, United StatesResponsibilities: Produce and validate biostatistics deliverables including CDISC datasets (SDTM/ADaM), Tables, Listings, and Figures (TLFs), and patient profiles using SAS. · Ensure high quality and accurate work in the programming process and consistency with the Statistical ...
-
Sr. SAS Clinical Programmer
4 days ago
Elajika Inc Boston, United States Full time, contractJob Title Sr. SAS Clinical ProgrammerLocation Boston MAExperience 2+Duration 6MonthsRoles and Responsibilities Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications datasets SDRG Annotated CRF) for Client studies Serve as Study SDTM Program ...
-
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 ...
-
Research Associate
17 hours ago
Point32Health Boston, United StatesWho We Are · Point32Health is a leading health and wellbeing organization, delivering an ever-better personalized health care experience to everyone in our communities. At Point32Health, we are building on the quality, nonprofit heritage of our founding organizations, Tufts Healt ...
-
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 ...
-
SVP, Head of Data Analytics
3 days ago
BioSpace, Inc. Waltham, United StatesJob Details · Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oli ...
-
SVP, Head of Data Analytics
6 days ago
Dyne Therapeutics Inc Waltham, United States Full timeCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide th ...
-
SVP, Head of Data Analytics
3 days ago
BioSpace, Inc. Waltham, United StatesJob Details · Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligon ...
-
SVP, Head of Data Analytics
3 weeks ago
Dyne Therapeutics Waltham, United States Full timeCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...
-
Clinical Programmer
5 days ago
LLX Solutions Waltham, United States Full timeWe have an immediate opening for an entry-level Clinical Programmer. · The Clinical Programmer is responsible for performing clinical programming activities for assigned clinical studies. This is a full time on-site position with great career development and advancement opportuni ...
-
Senior Statistical Programmer
2 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 ...
-
Director, Biostatistics
5 days ago
Deciphera Pharmaceuticals Waltham, United States Full timeJob Description · We are seeking a Director of Biostatistics to join our team. In this role, the successful candidate will serve as the lead study statistician on one or more drug programs, which may include complex and/or pivotal studies. The successful candidate may also lead r ...
-
Associate Director, Statistical Programming
3 weeks ago
Dyne Therapeutics Waltham, United States Full timeCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...
-
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 ...