Olema Oncology
Senior Director, Biostatistics
Olema Oncology, San Francisco, California, United States, 94199
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow‑on candidate, OP‑3136, is a potent KAT6 inhibitor with best‑in‑class potential.
About the Role Senior Director, Biostatistics
As the Senior Director of Biostatistics, reporting to the VP of Biostatistics, you will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will leverage your technical expertise to apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis, and collaborate cross‑functionally to support the planning, execution, and analysis of the trial. The role is based in either our San Francisco, CA or Cambridge, MA office and requires minimal travel (about 10 %).
Lead the biostatistics strategy and execution for a pivotal Phase 3 trial and ISS/ISE, ensuring scientific rigor and global regulatory alignment.
Apply innovative statistical methods to optimize study design, analysis strategies, and data interpretation.
Develop and author key statistical documents.
Lead statistical activities for regulatory submissions and prepare briefing materials for health authority interactions.
Provide statistical input for CSRs, IBs, DSURs, and other study‑level and submission documents.
Oversee development of SDTM, ADaM, and TLF deliverables to ensure accuracy and compliance with regulatory and CDISC standards.
Manage CRO statistical activities, including DMC deliverables, to ensure high‑quality execution.
Manage and mentor junior statisticians as applicable.
Provide statistical leadership across multiple projects with overlapping timelines, as needed.
Ideal Candidate Profile Knowledge
Strong understanding of regulatory requirements, industry standards, and guidance documents.
Broad and thorough knowledge of statistical principles and clinical trial methodology, with the ability to apply best practices in oncology study design and analysis.
Comprehensive understanding of RECIST 1.1 guidelines.
Expertise in CDISC standards, including SDTM and ADaM.
Proficiency in SAS and/or R programming.
Demonstrated ability to lead and successfully complete major programs and projects.
Strong analytical, problem‑solving, and communication skills.
Experience interacting with regulatory agencies, including the FDA and international health authorities.
Experience
10+ years of experience in the biotech or pharmaceutical industry, with a PhD in Statistics or Biostatistics.
Minimum of 3 years direct leadership experience.
Extensive experience in late‑stage oncology drug development, including the design and execution of registrational Phase 3 studies.
Proven experience in regulatory interactions, with a strong track record of NDA or sNDA submissions.
Experience building a biostatistics strategy and execution of a global NDA submission (Phase 3, ISS, ISE).
Demonstrated ability to manage CROs in the conduct and analysis of clinical trials.
Proven ability to represent Biostatistics effectively in multidisciplinary meetings.
Strong history of effective collaboration across cross‑functional teams.
Attributes
Strong leadership skills, including proactive strategic thinking, prioritization, adaptability, conflict resolution, and partnership‑building.
Deep statistical expertise and experience overseeing the statistical components of clinical trials.
Ability to develop innovative and creative statistical and technical solutions to complex problems.
Excellent verbal and written communication skills.
Commitment to excellence and consistently delivering high‑quality work.
Self‑motivated and enthusiastic, with the ability to quickly learn, identify core project challenges, and adapt to evolving requirements in a fast‑paced environment.
Possesses impeccable professional ethics, integrity, and judgment.
The base pay range for this position is expected to be
$292,000 – $308,000
annually; the actual base pay offered may vary depending on location, market, job‑related knowledge, skills, and experience. The total compensation package also includes equity, bonus, and benefits.
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 does not accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert:
We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in
@olema.com . Our official corporate website is
olema.com ; our careers page is
olema.com/careers ; our LinkedIn page is
linkedin.com/company/olema-oncology . Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in‑person interview.
#J-18808-Ljbffr
About the Role Senior Director, Biostatistics
As the Senior Director of Biostatistics, reporting to the VP of Biostatistics, you will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will leverage your technical expertise to apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis, and collaborate cross‑functionally to support the planning, execution, and analysis of the trial. The role is based in either our San Francisco, CA or Cambridge, MA office and requires minimal travel (about 10 %).
Lead the biostatistics strategy and execution for a pivotal Phase 3 trial and ISS/ISE, ensuring scientific rigor and global regulatory alignment.
Apply innovative statistical methods to optimize study design, analysis strategies, and data interpretation.
Develop and author key statistical documents.
Lead statistical activities for regulatory submissions and prepare briefing materials for health authority interactions.
Provide statistical input for CSRs, IBs, DSURs, and other study‑level and submission documents.
Oversee development of SDTM, ADaM, and TLF deliverables to ensure accuracy and compliance with regulatory and CDISC standards.
Manage CRO statistical activities, including DMC deliverables, to ensure high‑quality execution.
Manage and mentor junior statisticians as applicable.
Provide statistical leadership across multiple projects with overlapping timelines, as needed.
Ideal Candidate Profile Knowledge
Strong understanding of regulatory requirements, industry standards, and guidance documents.
Broad and thorough knowledge of statistical principles and clinical trial methodology, with the ability to apply best practices in oncology study design and analysis.
Comprehensive understanding of RECIST 1.1 guidelines.
Expertise in CDISC standards, including SDTM and ADaM.
Proficiency in SAS and/or R programming.
Demonstrated ability to lead and successfully complete major programs and projects.
Strong analytical, problem‑solving, and communication skills.
Experience interacting with regulatory agencies, including the FDA and international health authorities.
Experience
10+ years of experience in the biotech or pharmaceutical industry, with a PhD in Statistics or Biostatistics.
Minimum of 3 years direct leadership experience.
Extensive experience in late‑stage oncology drug development, including the design and execution of registrational Phase 3 studies.
Proven experience in regulatory interactions, with a strong track record of NDA or sNDA submissions.
Experience building a biostatistics strategy and execution of a global NDA submission (Phase 3, ISS, ISE).
Demonstrated ability to manage CROs in the conduct and analysis of clinical trials.
Proven ability to represent Biostatistics effectively in multidisciplinary meetings.
Strong history of effective collaboration across cross‑functional teams.
Attributes
Strong leadership skills, including proactive strategic thinking, prioritization, adaptability, conflict resolution, and partnership‑building.
Deep statistical expertise and experience overseeing the statistical components of clinical trials.
Ability to develop innovative and creative statistical and technical solutions to complex problems.
Excellent verbal and written communication skills.
Commitment to excellence and consistently delivering high‑quality work.
Self‑motivated and enthusiastic, with the ability to quickly learn, identify core project challenges, and adapt to evolving requirements in a fast‑paced environment.
Possesses impeccable professional ethics, integrity, and judgment.
The base pay range for this position is expected to be
$292,000 – $308,000
annually; the actual base pay offered may vary depending on location, market, job‑related knowledge, skills, and experience. The total compensation package also includes equity, bonus, and benefits.
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 does not accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert:
We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in
@olema.com . Our official corporate website is
olema.com ; our careers page is
olema.com/careers ; our LinkedIn page is
linkedin.com/company/olema-oncology . Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in‑person interview.
#J-18808-Ljbffr