Olema Oncology
Principal Statistical Programmer
Olema Oncology, San Francisco, California, United States, 94199
Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.
As the Principal Statistical Programmer reporting to the Senior Director of Statistical Programming, you will be accountable for all statistical programming deliverables in adherence to company SOPs and ICH/GCP. You will also help to create and implement Statistical Programming policies and procedures.
This role is based out of our San Francisco, CA office.
Your work will primarily encompass:
Strong ability to produce in-house ADaM datasets and TFLs for CSR and for other key deliverables is a must 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 high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc. Ensure timely delivery of all statistical deliverables for each study assigned Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items Follow departmental SOPs and processes for operational excellence Lead statistical programming activities for regulatory submissions following CDISC standards Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan Take ownership for the completion of SDTM and ADAM specifications for assigned studies Knowledge:
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation Thorough knowledge of SDTM/ADaM specifications and programming Strong SAS programming and graphic programming skills Able to guide the successful completion of major programs and projects Strong analytical and communication skills Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies Broad knowledge of medical/biological terminology in relevant therapeutic areas Experience:
12 years of related experience with a Bachelor's degree in Statistics; or 8 years and a Master's degree; or a PhD with 5 years experience Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses Experience with oncology trials is preferred Experience with R is a plus Experience with SAS Graphics is a plus Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus Experience in management of CROs with respect to statistical programming Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization Attributes:
Leadership skills in proactively prioritizing tasks, flexible to changes, conflict resolution, and effective partnership Strong verbal and written communication skills Effectively represent statistical programming in multidisciplinary meetings Commitment to excellence Self-motivated and enthusiastic, fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization Have impeccable professional ethics, integrity and judgement
The base pay range for this position is expected to be $184,000-$195,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-MK1
Important Information
>>>
We provide
equal opportunity to all employees and applicants for employment
and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a
competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Additional Note/Fraud Alert : Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,
please be vigilant in checking that the communication is in fact coming from Olema.
As the Principal Statistical Programmer reporting to the Senior Director of Statistical Programming, you will be accountable for all statistical programming deliverables in adherence to company SOPs and ICH/GCP. You will also help to create and implement Statistical Programming policies and procedures.
This role is based out of our San Francisco, CA office.
Your work will primarily encompass:
Strong ability to produce in-house ADaM datasets and TFLs for CSR and for other key deliverables is a must 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 high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc. Ensure timely delivery of all statistical deliverables for each study assigned Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items Follow departmental SOPs and processes for operational excellence Lead statistical programming activities for regulatory submissions following CDISC standards Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan Take ownership for the completion of SDTM and ADAM specifications for assigned studies Knowledge:
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation Thorough knowledge of SDTM/ADaM specifications and programming Strong SAS programming and graphic programming skills Able to guide the successful completion of major programs and projects Strong analytical and communication skills Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies Broad knowledge of medical/biological terminology in relevant therapeutic areas Experience:
12 years of related experience with a Bachelor's degree in Statistics; or 8 years and a Master's degree; or a PhD with 5 years experience Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses Experience with oncology trials is preferred Experience with R is a plus Experience with SAS Graphics is a plus Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus Experience in management of CROs with respect to statistical programming Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization Attributes:
Leadership skills in proactively prioritizing tasks, flexible to changes, conflict resolution, and effective partnership Strong verbal and written communication skills Effectively represent statistical programming in multidisciplinary meetings Commitment to excellence Self-motivated and enthusiastic, fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization Have impeccable professional ethics, integrity and judgement
The base pay range for this position is expected to be $184,000-$195,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-MK1
Important Information
>>>
We provide
equal opportunity to all employees and applicants for employment
and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a
competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Additional Note/Fraud Alert : Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,
please be vigilant in checking that the communication is in fact coming from Olema.