Senior Statistical Programmer

4 days ago

india Cytel Software Corporation Full time

LCC Senior Programmer

 

Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of one of our major pharma clients. Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.

 

We are experiencing exponential growth on a global scale and hiring Senior Statistical Programmers to join our FSP division.  You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, to support or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas. This role can be performed as fully remote.

 

Our values

 

We believe in applying scientific rigor to reveal the full promise inherent in data.

 

We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.

 

We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.

 

We prize innovation and seek intelligent solutions using leading-edge technology.

 

 

How you will contribute:

 

  • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming
  • Generating and validating analysis datasets/analysis files, and complex tables, listings, and figures ( TLFs)
  • Production and QC / validation programming
  • Generating complex ad-hoc reports utilizing raw data and analysis datasets
  • Applying strong understanding/experience of Safety and Efficacy analysis
  • Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
  • Performing lead duties for assigned clinical study under principle programmers oversight
  • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
  • Being adaptable and flexible when priorities change
  • Being able to create specifications for derived/analysis datasets
  • Generating and validating Non-CDISC transformation datasets and analysis datasets
  • Proficient knowledge with SDTM/ADaM and TLF’s.   General expertise with Figures
  • Individuals should be able to start programs from scratch and have the ability to handle complicated domains and outputs related to the protocol and SAP.
  • Creating and reviewing submission documents and eCRTs
  • They must demonstrate a good understanding of the endpoints and data collection, with the ability to read and write specifications related to the respective implementation guides.
  • R & complex macro writing are a plus

 

 

What you offer:

 

  • Bachelor’s or master’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
  • At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
  • Familiarity with drug development life cycle and experience with the analysis and reporting of clinical trials’ data.
  • Familiarity with ICH E3 (Structure and Content of CSR) and E9 (Stat Principles).
  • Well conversant with regulatory requirements and drug development process.
  • Study lead experience, preferably juggling multiple projects simultaneously.
  • Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH
  • Strong CDISC (both SDTM and and ADaM) experience is required.
  • Solid ADaM and complex TFL skills.
  • Strong QC / validation skills.
  • Good ad-hoc reporting skills. 
  • Experience in pooling/ ISS/SE studies is an asset.
  • Experience with cross-over studies is a plus.
  • Submissions experience utilizing define.xml, creation of annotated CRF, data reviewer’s guides and other submission documents.
  • Excellent analytical & troubleshooting skills.
  • Being flexible to adapt and use client’s macro codes.
  • R programming knowledge for data manipulation and graphs is an asset.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
  • Applied experience in one of the following therapeutic area is a plus: oncology, rare diseases, gastroenterology, respiratory, immunology, hepatitis and vaccines.
  • Experience in medical affairs is a plus.

 

 

  • Senior Statistical Programmer

    2 weeks ago

    India Dataceria Full time

    Statistical - Senior Programmer Ideal Candidate Should Posses the below Skills 1) Clinical SAS Programming 2) METEOR experience will be desirable 3) R Programming 4) SDTM, ADAM and TFLs 5) SDISC standards Field -SPC programming Preferred candidate profile - 5 to 8 years experience in Clinical SAS Programming with some hands on experience in Meteor...

  • Senior Statistical Programmer

    2 weeks ago

    India Acl Digital Full time

    Senior Statistical Programmer (6-8 years of exp)Location: Remote ROLES andRESPONSIBILITIES:Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADa M datasets as per the specifications for both Safetyand efficacy Develop and/or validate Tables,...

  • Senior Statistical Programmer

    2 months ago

    India ACL Digital Full time

    Senior Statistical Programmer (6-8 years of exp) Location: RemoteROLES and RESPONSIBILITIES:Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shellDevelop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safetyand efficacyDevelop and/or validate Tables,...

  • Senior Statistical Programmer

    2 months ago

    india ACL Digital Full time

    Senior Statistical Programmer (6-8 years of exp) Location: Remote ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safetyand efficacy Develop and/or validate Tables,...

  • Senior Statistical Programmer

    4 weeks ago

    India ACL Digital Full time

    Senior Statistical Programmer (6-8 years of exp) Location: Remote ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safetyand efficacy Develop and/or validate Tables,...

  • Senior Statistical Programmer

    4 weeks ago

    India ACL Digital Full time

    Senior Statistical Programmer (6-8 years of exp) Location: RemoteROLES and RESPONSIBILITIES:Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shellDevelop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safetyand efficacyDevelop and/or validate Tables,...

  • Senior Statistical Programmer

    2 weeks ago

    India Cytel Software Corporation Full time

    Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where...

  • Senior/ Principal statistical programmer

    2 weeks ago

    india Clintech Informatics Full time

    Company Description Clintech Informatics is a company dedicated to utilizing our extensive experience and qualifications in SAS and Statistics to provide unlimited opportunities for passionate individuals. We strive to give the golden touch of our expertise to the field, offering a platform for growth and innovation. Role Description This is a full-time...

  • Senior/ Principal statistical programmer

    2 weeks ago

    India Clintech Informatics Full time

    Company Description Clintech Informatics is a company dedicated to utilizing our extensive experience and qualifications in SAS and Statistics to provide unlimited opportunities for passionate individuals. We strive to give the golden touch of our expertise to the field, offering a platform for growth and innovation. Role Description This is a full-time...

  • Senior Statistical Programmer

    3 days ago

    India TK-Chain® Full time

    Title: Statistical Programmers Are you a talented Statistical Programmer with a passion for SDTM and ADaM? We have an exciting opportunity for you!Position: Statistical Programmer Location: IndiaExperience: 4+ yearsResponsibilities:Develop and validate SDTM and ADaM datasets according to regulatory standards.Collaborate with cross-functional teams to ensure...

  • Senior Statistical Programmer

    2 days ago

    india TK-Chain® Full time

    Title: Statistical Programmers Are you a talented Statistical Programmer with a passion for SDTM and ADaM? We have an exciting opportunity for you! Position: Statistical Programmer Location: India Experience: 4+ years Responsibilities: Develop and validate SDTM and ADaM datasets according to regulatory standards. Collaborate with cross-functional teams to...

  • Statistical Programmer

    2 weeks ago

    India CosMic IT Full time

    Full Time - India - Posted 11 months ago - Applications have closed - CosMicIT **CosMic IT** - Find Your Dream Job Here_ Hello #Everyone, We at #CosMicIT are looking for #Statistical Programmer Language: #English Locations: #India Summary: R/Python exp/knowledge, knowledge/exp of eCRF & SQL. 1. 1 to 4 years of experience in programming related...

  • Statistical Programmer Ii

    3 weeks ago

    India Novotech Asia Full time

    The Statistical Programmer II is primarily responsible for undertaking all statistical programming tasks on one or more clinical studies under the supervision of more senior Statistical Programmers and/or Statistical Programming Management. The SP II works closely with the project biostatisticians and other project stakeholders to plan and assist with...

  • Statistical Programmer

    2 weeks ago

    India Cytel, India Full time

    Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where...

  • Statistical Programmer

    2 weeks ago

    India Cytel, India Full time

    Working under the direction of Senior Statistical Programmer/Team Lead, the **Statistical Programmer** conducts programming activities for a trial, early-phase project, indication, or publication activities. **Responsibilities include**: - Read and understand the program specifications document. - Prepare SAS analysis datasets, tables, listings, and...

  • Senior Statistical Programmer

    2 weeks ago

    India Cytel Full time

    Sr. Statistical Programmer - FSP (India) 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. Key Responsibilities: Effectively designs and codes SAS programs...

  • Statistical Programmer

    2 weeks ago

    India CosMic IT Full time

    Full Time India Posted 7 mins ago CosMicITCosMic IT Find Your Dream Job Here_Hello #Everyone,We at #CosMicIT are looking for #Statistical ProgrammerLanguage: #EnglishLocations: #IndiaSummary:1. 1 to 4 years of experience in programming related activities for clinical studies (Phase I to IV) and publicationAdvance knowledge of Base SAS, SAS / STAT, SAS /Graph...

  • Senior Statistical Programmer

    2 months ago

    india Cytel Full time

    Sr. Statistical Programmer - FSP (India) 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. Key Responsibilities: Effectively designs and codes SAS...

  • Senior Statistical Programmer

    4 weeks ago

    india Cytel Full time

    Sr. Statistical Programmer - FSP (India) 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. Key Responsibilities: Effectively designs and codes SAS...

  • Statistical Programmer

    2 weeks ago

    India Cytel Full time

    Working under the direction of Senior Statistical Programmer/Team Lead, the Statistical Programmer conducts programming activities for a trial, early-phase project, indication, or publication activities. Responsibilities include: Read and understand the program specifications document. Prepare SAS analysis datasets, tables, listings, and figures...