- Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
- Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets
- Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements
- Provides input in the design and development of case report forms and clinical databases
- Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs
- Programs quality checks for clinical study raw data and report the findings to Data Management
- Provides input in the design and development of case report forms and clinical study databases
- Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming
- Provides programming support for adhoc analysis
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
- Manages timelines and schedules of specific phases of projects with internal personnel and external vendors
- Acts as lead programmer for a study
- Reviews or validates statistical deliverables of vendors for assigned project(s)
- MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years.
- Experience in providing statistical programming support to early and late phase clinical trials.
- Excellent skills in SAS programming and statistical reporting.
- Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
- Familiarity with FDA and ICH regulations and guidelines.
- Excellent problem-solving skills.
- Good written and verbal communication skills and organizational and documentation skills.
- Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
- Ability to prioritize and multi-task effectively
- Demonstrated positive attitude and the ability to work well with others.
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Senior Statistical Programmer
2 weeks 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 ...
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Principal Statistical Programmer
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Beacon Therapeutics (USA) Inc Cambridge, United StatesJob Description · Job DescriptionExciting opportunity for an experienced Clinical Statistical Programmer to join our team at Beacon Therapeutics (USA) Inc. as a Full Time Principal Statistical Programmer. In this fully remote position, you will have the chance to showcase your ex ...
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Senior Statistical Programmer
1 week 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 ...
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Principal Statistical Programmer
1 week 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 ...
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Principal Statistical Programmer
1 week ago
Prometrika Boston, MA, 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 ...
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Senior Statistical Programmer
1 week ago
Galderma Boston, United States Full timeWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans th ...
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Senior Statistical Programmer
2 weeks 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 ...
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Principal Statistical Programmer
3 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 ...
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Manager, Statistical Programmer
3 weeks 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 ...
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Manager, Statistical Programmer
1 week ago
Takeda Development Center Americas, Inc Lexington, United StatesTakeda Development Center Americas, Inc. is seeking a Manager, Statistical · Programmer in Lexington, MA to Lead study level programming and oversight activities ensuring quality and timelines; lead multiple studies, activities and parts of projects including studies or explorat ...
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Statistical Programmer/Data Analyst RECOVER
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Mass General Brigham Boston, United States RegularStatistical Programmer/Data Analyst RECOVER Description Massachusetts General Hospital (MGH) Biostatistics is seeking a Statistical Programmers/Data Analysts to join our team working on the National Institutes of Health (NIH) sponsored project, an initiative to understand, prev ...
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Principal Statistical Programmer
3 weeks 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 ...
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Principal Statistical Programmer
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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 ...
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Principal Statistical Programmer
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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 ...
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Biostatistician, Statistical Programmer
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TechData Service Company LLC Bridgewater, United StatesJob Description · Job DescriptionResponsibilities · At project level, ensures the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements. · Provide statistical support to Clinical Development Plan for multiple compounds · Participa ...
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Remote Principal Statistical Programmer
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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 ...
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Clinical SAS Programmer
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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 ...
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Data Scientist
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Amgen Cambridge, United States**HOW MIGHT YOU DEFY IMAGINATION?** · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients ...
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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 ...
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Manager, Safety Statistical Programming
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AbbVie Boston, United States**Company Description** · The Manager of Safety Statistical Programming is a strategic role in the emerging field of safety science providing programming expertise for development of pooled safety data sets and providing technical guidance to team of Statistical Programmers in th ...
Senior Statistical Programmer - Cambridge, United States - Sarepta Therapeutics
Description
Serves as a stat programming expert or point of contact for assigned clinical studies under close/limited supervision of the stat programming project leadPrimary Responsibilities Include:
This position is remote.
However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $100,000 - $125,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
