Gossamer Bio
Manager Statistical Programming
Gossamer Bio, San Diego, California, United States, 92189
Job Summary
Responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. Works closely with Biostatisticians and Data Managers to support creating SAS programs for independently validating selected tables, listings, and figures produced by programming vendors, for ad-hoc analyses, and to assist with data cleaning and query generation. Independently produces selected SDTM/ADaM files for analysis preparation and for validation of CRO CDISC work. Serves as a contact for programming activities being performed at assigned CROs.
Essential Duties and Responsibilities
Provides SAS programming support to all clinical studies.
Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables.
Provides statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
Provides primary programming and QC support for any internally produced outputs.
Reviews and approves SAS programming instructions and CDISC/ADaM specifications.
Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming.
Works closely with biostatisticians and other functions (Pharmacovigilance, Clinical Development, etc.) to support data review for internal stakeholders.
Assists with ensuring consistency across programming methods in similar studies within a program.
Provides project management support, as needed, to ensure quality and timely completion of study milestones.
Creates programming related SOPs, as necessary.
Contributes to the management and administration of the Biometrics SAS server.
Contributes to establishing and maintaining internal SAS programming conventions.
Job Qualifications
Education, Certifications, Experience
Bachelor’s Degree equivalent with a minimum of 6 years of experience in SAS programming with at least 5 of those in a clinical research setting, or Master’s Degree with a minimum of 4 years of experience in SAS programming with at least 2 of those in a clinical research setting. Prefer industry experience in all phases of clinical research.
Knowledge, Skills and Abilities
Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 5 years of pharmaceutical experience required.
Experience with BLA or NDA/sNDA submissions is required.
Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
In depth knowledge of CDISC and ADaM dataset structures and requirements.
Proficiency with SAS programming skills including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL). Knowledge of all aspects of clinical drug development (Phase 1-4).
Experience working with and managing a CRO partner.
Excellent computer skills; strong verbal and written communication skills.
Ability to work well in a team environment as a contributor.
Open, engaging, and transparent work style.
Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a very fast-paced environment.
Special Working Conditions
Office environment / Domestic - travel up to 10% may be necessary.
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
For California based applicants, the expected salary range for this position is
$145,000 to $155,000 . Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. Gossamer Bio is a multi-state employer, and this salary range may not reflect positions that work in other states.
This position is preferably located in San Diego, CA, however, we welcome candidates from all US territories as working remotely is a possibility.
This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching, long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit
https://www.gossamerbio.com/work-at-gossamerbio/
#J-18808-Ljbffr
Responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. Works closely with Biostatisticians and Data Managers to support creating SAS programs for independently validating selected tables, listings, and figures produced by programming vendors, for ad-hoc analyses, and to assist with data cleaning and query generation. Independently produces selected SDTM/ADaM files for analysis preparation and for validation of CRO CDISC work. Serves as a contact for programming activities being performed at assigned CROs.
Essential Duties and Responsibilities
Provides SAS programming support to all clinical studies.
Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables.
Provides statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
Provides primary programming and QC support for any internally produced outputs.
Reviews and approves SAS programming instructions and CDISC/ADaM specifications.
Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming.
Works closely with biostatisticians and other functions (Pharmacovigilance, Clinical Development, etc.) to support data review for internal stakeholders.
Assists with ensuring consistency across programming methods in similar studies within a program.
Provides project management support, as needed, to ensure quality and timely completion of study milestones.
Creates programming related SOPs, as necessary.
Contributes to the management and administration of the Biometrics SAS server.
Contributes to establishing and maintaining internal SAS programming conventions.
Job Qualifications
Education, Certifications, Experience
Bachelor’s Degree equivalent with a minimum of 6 years of experience in SAS programming with at least 5 of those in a clinical research setting, or Master’s Degree with a minimum of 4 years of experience in SAS programming with at least 2 of those in a clinical research setting. Prefer industry experience in all phases of clinical research.
Knowledge, Skills and Abilities
Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 5 years of pharmaceutical experience required.
Experience with BLA or NDA/sNDA submissions is required.
Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
In depth knowledge of CDISC and ADaM dataset structures and requirements.
Proficiency with SAS programming skills including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL). Knowledge of all aspects of clinical drug development (Phase 1-4).
Experience working with and managing a CRO partner.
Excellent computer skills; strong verbal and written communication skills.
Ability to work well in a team environment as a contributor.
Open, engaging, and transparent work style.
Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a very fast-paced environment.
Special Working Conditions
Office environment / Domestic - travel up to 10% may be necessary.
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
For California based applicants, the expected salary range for this position is
$145,000 to $155,000 . Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. Gossamer Bio is a multi-state employer, and this salary range may not reflect positions that work in other states.
This position is preferably located in San Diego, CA, however, we welcome candidates from all US territories as working remotely is a possibility.
This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching, long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit
https://www.gossamerbio.com/work-at-gossamerbio/
#J-18808-Ljbffr