Principal/Senior- Statistical Programmer
Overview:
Principal /Senior -Statistical Programmer -Remote IndiaAs an experienced programmer, you will hold a combined project leadership and hands-on technical statistics role. Working across a defined area within the sponsor team you will be leading studies and working on sponsor systems
Responsibilities:
Program and validate datasets and SDTMs, including complex efficacy, labs, etc.Adhere to client SOPs and work on client systemsOversight of Vendor ProgrammingKnowledge of FDA CRT requirements including define.xml and define.pdfLead team and be responsible for creation of CRT packagesBecome independent technical expertProgram complex non efficacy outputs/ figuresPerform Senior Review and Deliver QC of non- statistical outputBecome involved in developing the standard macro library and take responsibility to implement standard macros within a studyValidate and perform User Acceptance Testing (UAT) on standard macrosIdentify macros requirements, communicate and perform trainingCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.
Qualifications:
Educated to BSc or above within Computer Science, Mathematics or a Science related disciplineGood awareness of clinical trial issues, design, and implementationIn-depth knowledge of SDTM, including but not limited to controlled terminologyExperience in ECRT package preparation (aCRF, Define.xml, cSDRG)Strong programming skillsAbility to lead projects and work independentlyStrong SAS programming and clinical trial experiencePrior experience in RWD projects is preferred but not essential.Apply Now! Be part of a team known for technical expertise, quality, and impact. We value Excellence, Collaboration, Integrity, Innovation, and Passion—and we seek team members who embody these qualities. Apply today! Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Apply Now
Principal /Senior -Statistical Programmer -Remote IndiaAs an experienced programmer, you will hold a combined project leadership and hands-on technical statistics role. Working across a defined area within the sponsor team you will be leading studies and working on sponsor systems
Responsibilities:
Program and validate datasets and SDTMs, including complex efficacy, labs, etc.Adhere to client SOPs and work on client systemsOversight of Vendor ProgrammingKnowledge of FDA CRT requirements including define.xml and define.pdfLead team and be responsible for creation of CRT packagesBecome independent technical expertProgram complex non efficacy outputs/ figuresPerform Senior Review and Deliver QC of non- statistical outputBecome involved in developing the standard macro library and take responsibility to implement standard macros within a studyValidate and perform User Acceptance Testing (UAT) on standard macrosIdentify macros requirements, communicate and perform trainingCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.
Qualifications:
Educated to BSc or above within Computer Science, Mathematics or a Science related disciplineGood awareness of clinical trial issues, design, and implementationIn-depth knowledge of SDTM, including but not limited to controlled terminologyExperience in ECRT package preparation (aCRF, Define.xml, cSDRG)Strong programming skillsAbility to lead projects and work independentlyStrong SAS programming and clinical trial experiencePrior experience in RWD projects is preferred but not essential.Apply Now! Be part of a team known for technical expertise, quality, and impact. We value Excellence, Collaboration, Integrity, Innovation, and Passion—and we seek team members who embody these qualities. Apply today! Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Apply Now